Research Review By Dr. Keshena Malik©

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Date Posted:

July 2015

Study Title:

Manipulative therapy & rehabilitation for recurrent ankle sprain with functional instability: A short-term, assessor-blind, parallel-group randomized trial

Authors:

Lubbe D, Lakhani E, Brantingham JW et al.

Author's Affiliations:

Department of Chiropractic and Somatology, Durban University of Technology, Durban, South Africa; School of Chiropractic and Sports Science, Murdoch University, Perth, Australia; Rockingham General Hospital, Rockingham, Australia; Global Health Ergonomics, Amgen Inc, Thousand Oaks, California.

Publication Information:

Journal of Manipulative & Physiological Therapeutics 2015; 38(1): 22–34.

Background Information:

Recurrent ankle sprain with functional instability (RASFI) is a common ankle disorder, with more than 40% of inversion sprain injuries progressing beyond RASFI to chronic ankle instability (CAI) (1, 2). Approximately 85% of all ankle injuries result from forced inversion and plantar flexion, which is the primary cause of recurrent inversion sprain (3). Inversion ankle sprain is one of the most common injuries in sport, representing 10% to 30% of all sports injuries, being particularly common in court and contact team sports (4, 5). Inversion sprain is a cause of significant absence from sport, with a high rate of recurrent sprains or persistent symptoms in athletes upon their return (4, 6). Such injury is estimated to account for 15% of all athletic injuries and up to 72% of all athletes will sustain chronic or long-term ankle signs and symptoms (lasting ≥ 18 months) (4, 5, 7).

Inversion ankle injury occurs first to the anterior talofibular ligament, then calcaneofibular and finally the posterior talofibular ligaments with associated increase in severity, chronic pain, altered gait and significant loss of dorsiflexion (4, 5, 7). These features of RASFI, including restricted ankle dorsiflexion range of motion (ROM), are thought to result from a loss of anterior-to-posterior (A-P) talar glide with associated intermittent pain which prevents the locking of the ankle mortise joint into dorsiflexion, leaving the ankle slightly plantar flexed and inherently less stable and predisposed to recurrent sprain (6, 8-10). According to the literature, RASFI is defined as the same ankle, sprained on at least two occasions, with associated feelings of instability, or reports of ‘giving way’ with continued pain and impaired proprioception, neuromuscular balance and control – becoming a recurrent and chronic problem lasting months in duration (2, 5-11).

A combination of early proprioceptive and strength training is advocated after inversion sprain to reduce symptoms of RASFI and avoid progression to CAI (1, 12-14). Joint mobilization and manipulation of the foot/ankle joints are emerging as promising treatments for ankle sprain and often form part of a package of care in clinical practice, as an adjunct to rehabilitation (4, 15). It is unclear, however, if the addition of manipulative therapy (MT) to rehabilitation will show a benefit over rehabilitation alone in terms of pain and disability. The goal of this study was to evaluate this concept.

Pertinent Results:

Over the 3-month recruitment period from August to November 2010, 52 potential participants were screened and assessed; 33 were eligible for the study and consented to participate. Eighteen participants were randomized to group 1 (rehabilitation alone) and 15 participants randomized to group 2 (MT plus rehabilitation). Descriptive and participant characteristics suggested that the 2 groups were similar at baseline and the average participant was a young adult of healthy weight who had experienced chronic symptoms and had repeatedly injured his/her ankle.

Group Comparison:
Between-group statistical analysis did not reveal a significant difference in scores at the same time point for the FADI (p = 0.26), however, there were statistically significant differences in scores at week 5 for VAS and for frequency of joint restrictions determined by motion palpation (p < 0.0059, p < 0.0001, respectively).

Clinical Application & Conclusions:

Overall, it seems that both treatment approaches were statistically significant and useful, but the addition of MT offered a greater improvement in pain and potentially joint restrictions.

It appears that in participants were pain is the prominent symptom, the early addition of MT may be clinically useful, allowing potentially improved rehabilitation and use of the joint in order to diminish the likelihood of developing disability (6, 27).

Study Methods:

A single-center, assessor-blind, parallel-group clinical trial with balanced randomization and 1- and 3-month follow-up was conducted at Durban University outpatient teaching clinic. Potential study candidates with ankle pain who were seeking care were screened by the primary researcher.

Screening criteria were as follows:
  • History of inversion sprains
  • Mortise joint tenderness/pain
  • No injury or sprain to their affected ankle in the last 6 weeks
Inclusion criteria

Diagnosis of RASFI:
  • With or without mild to moderate (grades I or II) localized bruising over the area of inversion sprain
  • With or without moderate localized swelling over the area of injury
  • Tenderness or pain of the injured area
  • Recurrent subjective feeling of giving way of the ankle
  • A history of recurrent sprains
  • No (or minimal) varus laxity of the mortise joint (determined by assessing clinician on exam based on talar tilt less than approximately 5 degrees beyond the opposite normal)
  • No or minimal anterior drawer sign (determined by assessing clinician on exam less than approximately 5mm)
Further inclusion criteria:
  • Age 18-45 (limit of 45 years of age to exclude possible degenerative change in the ankle/foot)
  • Baseline Visual Analogue Scale (VAS) score between 20-70mm; Foot and Ankle Disability Index (FADI) scores between 50-90 points
  • Restricted motion on joint palpation of affected foot/ankle
  • Washout period of 3 days for those eligible patients taking analgesic, anti-inflammatory or muscle relaxant medication(s)
Exclusion criteria
  • Full, pain-free ROM of the ankle without joint restriction(s)
  • Significant gross ligamentous laxity (varus and anterior drawer) of affected ankle (determined by assessing clinician on exam of greater than 5mm and 5 degrees, respectively, beyond opposite normal)
  • Acute injury or acute re-injury of the affected ankle 6 weeks prior to or during the study
  • General exclusion criteria included significant balance disorders, neurological disease unrelated to the affected ankle joint and contraindications to manipulative or rehabilitation therapy (i.e. connective tissue disorders or peripheral vascular disease)
Interventions:

Group 1: Rehabilitation Alone

The rehabilitation protocol consisted of fibular (peroneal) muscle strengthening and proprioceptive training as follows:
  • Fibular/Peroneal muscle strengthening performed using a wide elastic band of known resistance. The participant wrapped one end of the band around the outside of the affected foot and the other end to a sturdy object (e.g., table) perpendicular to the leg. With the affected leg straight and heel on the floor, the participant would evert the foot against the resistance. The exercise was implemented with a graded increase in sets/repetitions over time, with ideal being 3 sets of 12-15 repetitions per set, resulting in mild-to-moderate fatigue during the last set (16).
  • Proprioceptive training was performed on a wobble board and participants were required to stand on the board for 10 minutes. If the task was too difficult, a graded approach was used where the participant could hold on to a bar/wall to assist with the exercise (17).
The rehabilitation program was to be performed daily by the participant over the duration of the 5 week treatment period (maximum of 35 sessions, 5 weeks x 7 days) (18). The primary researcher instructed each participant on how to perform the rehabilitation protocol at the first consultation and subsequently the protocol was completed at home. Instructions were provided in an exercise diary which participants were requested to complete.

Group 2: Rehabilitation plus Manipulative Therapy (MT)

This group received rehabilitation program as described above (16-18) plus MT to mortise, subtalar and/or tarsal joints in the form of high-velocity, low-amplitude (HVLA) thrust-type manipulation. The joints to be manipulated were determined by a blind assessor and experienced chiropractor using palpation (of talocrural, subtalar and tarsal joints), ROM, and motion palpation techniques and restricted/hypomobile joints recorded. Participants received 6 MT treatments as an adjunct to rehabilitation over the same 5 week treatment period, with a 1-day rest period between treatments (19). The participants received a maximum of 29 exercise sessions (5 weeks x 7 days, 6 rest days), as per guidelines on reporting parallel-group randomized trial designs (20).

Palpation techniques were as follows:
  • Talocrural joint: in axial elongation or distraction (‘mortise separation’) and talus anterior-to-posterior (A-P) palpation with the ankle in or near neutral; restrictions in either motion were treated
  • Subtalar joint: the calcaneus was assessed in eversion or occasionally inversion and axial elongation or with distraction of the calcaneus.
  • Midtarsal joint: assessed in plantar-to-dorsal or dorsal-to-plantar medially and laterally glided and for general flexibility of the forefoot on the midfoot in circumduction (6, 21).
Manipulative Therapy (MT) Technique was as follows:
The treating chiropractor could freely choose a MT technique to address the identified joint restrictions. Usually a high-velocity low-amplitude (HVLA) grade V manipulation was used, occasionally a grade IV mobilization 2 to 5 times before delivery of a grade V manipulation. If there was pain or intolerance regarding the amplitude of manipulation then, 2 to 5 grade III mobilizations were applied before a grade IV mobilization.

The HVLA grade V manipulation included one of the following (21-22):
  1. Ankle axial elongation (or distraction), with or without added A-P combined movement of the talus, occasionally A-P manipulation of the talus with the ankle held in dorsiflexion.
  2. Eversion of the calcaneus (rarely inversion) or subtalar joint, midtarsal talonavicular or midtarsal calcaneocuboid joint dorsal-to-plantar mobilization or midtarsal figure 8 mobilization.
  3. Plantar-to-dorsal ‘snap’ technique used on the cuboid and other plantar intertarsal joints and modification of the ‘mortise separation’ or axial elongation technique of the tarsal could be used on the small tarsals for restricted dorsal-to-plantar glide.
Outcome Measures

The FADI and VAS for pain were the primary outcome measures (OM), joint motion palpation was the secondary OM.

FADI:
The FADI is a region-specific self-report of function related to daily living with a 26-item questionnaire that contains 4 pain-related items and 22 activity-related items. Each question is scored on a Likert scale (0-4: ranging from “no pain” to “unbearable”; “no difficulty at all” to “unable to do”) with a total possible best score of 104 points. The total score is then transformed into a percentage to give an indication of the degree of disability (i.e., the higher the score, the better the ankle function). This OM has satisfactory sensitivity and reliability with an approximated minimally clinically important difference of 8 points in ankle sprain injuries (23, 24).

VAS:
The VAS is a 100mm scale where 0mm represents “no pain” and 100mm represents the “worst imaginable” pain. In ankle injury research a minimally clinically important difference of approximately 20-30mm is generally reported (25, 26).

Joint Motion Palpation:
Joint motion palpation was used to determine the presence of joint restrictions (21, 22) before or after treatment as a secondary OM. The validity and reliability of joint motion palpation is debatable, however it is commonly used in clinical practice to provide supplementary data. A blind assessor and experienced chiropractor palpated each participant’s foot/ankle and recorded the findings which were used to inform the selection of manipulative treatment/techniques used.

Sample Size Estimation, Randomization and Data Management:

Sample Size:
A conservative effect size of 0.3 to offer power of more than 80% for repeated measures ANOVA and accounting for a 20% drop-out rate a minimum sample size of 30-34 (at least 15 per group) was considered satisfactory.

Randomization and Data Management:
Computer-generated random numbers, randomization and tabulation of participant allocation were completed prior to commencement of the study by an independent statistician. Participants and clinicians allocated to the treatment groups were aware of the allocation, the data collection and the data analysis researcher were blinded to allocation. Two clinical assistants were blind to treatment received by participants (i.e., one assistant palpated the participants foot/ankle to determine joints to be manipulated and the second assistant collected the data using the OMs).

Study Strengths / Weaknesses:

Strengths:
  • The use of blinded and experienced clinician assessors provided a greater ability to detect and define joint restrictions through motion palpation and reduce the potential for examination and treatment bias.
  • Randomized participants to each treatment group.
  • The sample size was adequate for study purposes.
  • This study provides insight into the benefits of MT as an adjunct to standard rehabilitation treatment for RASFI.
Weaknesses:
  • There was no ‘control’ group featuring either no treatment or a placebo treatment, therefore we are unable to definitively conclude the effectiveness of the individual treatments.
  • Intraexaminer reliability of the anterior drawer test is low and talar tilt test is unreliable, therefore it was suggested by the authors to use arthrotomy in the future (28).
  • The number of rehabilitation sessions performed by each group was not balanced (MT plus rehabilitation group = 30-33 sessions vs. rehabilitation alone group = 27-31 sessions). There was a significant 2-session difference between the groups which may have influenced the outcome.
  • The same clinician did not perform joint palpation and then apply the manual/MT treatment in order to reduce examination bias. This, however, does not mimic real-life clinical practice since clinicians use palpation to identify joint restrictions and treat accordingly.
  • The definition of chronicity in this study was > 7 weeks, while other studies define chronicity (as in CAI) as symptoms ≥ 6 months (2). It appears that this study may only reflect the early development of CAI.
  • The natural history of RASFI may have accounted for the improvement seen in each treatment group (i.e., Hawthorne effect).
  • The authors encouraged compliance to home rehabilitation and used a self-report exercise diary. In order to ensure compliance and appropriate performance of the exercises, it is suggested that facility-based supervised exercises be completed in future studies.

Additional References:

  1. Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin 2006; 11: 531-7.
  2. Hiller CE, Kilbreath SL, Refshauge KM. Chronic ankle instability: evolution of the model. J Athl Train 2011; 46: 133-41.
  3. Ferran NA, Maffulli N. Epidemiology of sprains of the lateral ankle ligament complex. Foot Ankle Clin 2006; 11: 659-62.
  4. Whitman JM, Cleland JA, Mintken PE, et al. Predicting shortterm response to thrust and nonthrust manipulation and exercise in participants post inversion ankle sprain. J Orthop Sports Phys Ther 2009; 39: 188-200.
  5. Holmes A, Delahunt E. Treatment of common deficits associated with chronic ankle instability. Sports Med 2009; 39: 207-24.
  6. Donovan L, Hertel J. A new paradigm for rehabilitation of participants with chronic ankle instability. Phys Sportsmed 2012; 40: 41-51.
  7. Sefton JM, Hicks-Little CA, Hubbard TJ, et al. Sensorimotor function as a predictor of chronic mortise instability. Clin Biomech 2009; 24: 451-8.
  8. Vicenzino B, Branjerdporn M, Teys P, et al. Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain. J Orthop Sports Phys Ther 2006; 36: 464-71.
  9. Delahunt E. Neuromuscular contributions to functional instability of the ankle joint. J Bodyw Mov Ther 2007; 11: 203-13.
  10. Delahunt E, Coughlan GF, Caulfield B, et al. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc 2010; 42: 2106-21.
  11. Hubbard TJ, Kramer LC, Denegar CR, et al. Contributing factors to chronic ankle instability. Foot Ankle Int 2007; 28: 343-54.
  12. Richie DH. Functional instability of the ankle and the role of neuromuscular control: a comprehensive review. J Foot Ankle Surg 2001; 40: 240-51.
  13. Delahunt E, Monaghan K, Caulfield B. Ankle function during hopping in subjects with functional instability of the ankle joint. Scand J Med Sci Sports 2007; 17: 641-8.
  14. Reid C. Sports Injury Assessment and Rehabilitation. New York: Churchill Livingstone; 1992217-50.
  15. Cleland JA, Mintken PE, McDevitt A, et al. Manual physical therapy and exercise versus supervised home exercise in the management of participants status post inversion ankle sprain: A multi-center randomized clinical trial. J Orthop Sports Phys Ther 2013; 43: 443-55.
  16. Mattacola CG, Dwyer MK. Rehabilitation of the ankle after acute sprain or chronic instability. Athl Train 2002; 37: 413-29.
  17. Hintermann B. Biomechanics of the unstable ankle joint and clinical implications. Med Sci Sports Exerc 1999; 31(7 Suppl): 459-69.
  18. Clark VM, Burden AM. A 4-week wobble board exercise program improved muscle onset latency and perceived stability in individuals with a functionally unstable ankle. Phys Ther Sport 2005; 6: 181-7.
  19. Köhne E, Jones A, Korporaal C, et al. A prospective, single-blinded, randomized, controlled clinical trial of the effects of manipulation on proprioception and ankle dorsiflexion in chronic recurrent ankle sprain. J Am Chiropr Assoc 2007; 44: 7-17.
  20. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ 2010; 340: c869.
  21. Bergmann T, Peterson DH. Chiropractic principles and procedures. St Louis: Mosby; 2010364-81.
  22. Schafer RC, Faye LJ. Motion palpation and chiropractic technique: principles of dynamic chiropractic. Huntington Beach, CA: The Motion Palpation Institute; 1990332-52.
  23. Hale SA, Hertel J. Reliability and sensitivity of the Foot and Ankle Disability Index in subjects with chronic ankle instability. J Athl Train 2005; 40: 35-40.
  24. Eechaute C, Vaes P, Van Aerschot L, et al. The clinimetric qualities of patient-assessed instruments for measuring chronic ankle instability: a systematic review. BMC Musculoskelet Disord 2007; 8: 6.
  25. Jensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. New York: Guilford Press; 1993.
  26. Salaffi F, Stancati A, Silvestri CA, et al. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004; 8: 283-91
  27. Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther 2001; 24: 17-24.
  28. de Vries JS, Krips R, Sierevelt IN, et al. Interventions for treating chronic ankle instability. Cochrane Database Syst Rev 2011:CD004124.