Comparing Manipulation and Rehabilitation to Rehabilitation Only, in the Management of Chronic Ankle Instability

NCT01196949 | Unknown

• 1 other identifier: CCC08132010A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that a combination approach would produce increased clinically and statistically significant outcomes as opposed to standard single intervention, inclusive of comparatively greater reduction in pain, improvement in range of motion, proprioception and function with an associated quicker recovery time. Chronic ankle instability (CAI) is a frequently encountered condition of the musculoskeletal system. Various individual treatment options have previously been compared to one another in clinical trials, however there is paucity of literature with regards to combined treatment choices versus individual therapy. The purpose of this study is to investigate the relative effectiveness of combined manipulation and rehabilitation versus rehabilitation only, in the management of CAI. The study will be conducted as a single blinded randomised and comparative clinical trial at Cleveland Chiropractic College and Durban University of Technology.

Conditions

Chronic Ankle Instability

Keywords

Ankle; Chronic; Instability; Manipulative; Rehabilitative; Manipulation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Gold standard subjective pain scale

  3months

Secondary Outcomes (1)

• Foot Ankle Disability Index

  3 months

Study Arms (2)

Manipulative and Rehabilitative Therapy

ACTIVE COMPARATOR

Other: Manipulative and Rehabilitative Therapy

Rehabilitative Therapy

ACTIVE COMPARATOR

Other: Rehabilitative Therapy

Interventions

Manipulative and Rehabilitative Therapy OTHER

Participants will receive 6 treatments over a 3 to 5 week time frame. A minimum of one day and maximum of 3 days between treatments. This group will receive high velocity low amplitude thrust to a minimum of 1 and maximum of 3 restricted segments within the mortise joint, subtalar joint and tarsal along with the same rehabilitation protocol as the other group.

Manipulative and Rehabilitative Therapy

Rehabilitative Therapy OTHER

Participants will receive education and training in the home exercises. This group is only required to attend the treatment facility for outcome measure readings and if they have any questions about the research protocol or check if they are performing their exercises correctly. A Theraband will be utilized for the peroneal muscle strengthening; 3 sets of 12 repetitions. Proprioception will be conducted on a Bosu Ball; 10 minutes per period. This protocol will be conducted everyday at home for the 5 week study. A diary will be required to record compliance and indicate how exercises should be performed.

Rehabilitative Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with grade one (Grade I: evidence of minimal swelling with minimal dysfunction, point tenderness over joint, absence of positive anterior drawers sign) or grade two (Grade II: moderate amount of swelling and haemorrhage over the ankle with pain more do on weight bearing). Potentially positive anterior drawers sign but with no varus laxity CLAI (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).
• Participants between the ages of 18 - 45 years (Pellow and Brantingham, 2001; Chowdry et al, 2003; Parker, 2005).
• Participants that are clinically diagnosed as having CLAI: the presence of 4 or more of a combination of symptoms including lateral ankle pain, joint weakness, oedema (Tatro-Adams et al, 1995), joint crepitus, adhesions resulting in the formation of fixations in the joint and ligamentous laxity (Reid, 1992; Pellow and Brantingham, 2001; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007).
• Participants with a visual analogue scale (vas) (Liggins, 1982; Salaffi et al, 2003) score of between 20 and 70 millimetres to maintain homogeneity within the sample (Mouton, 1996).
• Participants with a foot/ankle disability Index (FADI) (Hale and Hertel, 2005) of between 50 and 90 to maintain homogeneity within the sample (Mouton, 1996).
• Participants with a berg balance scale (Kornetti et al, 2004) of less than 45/56 to maintain homogeneity within the sample (Mouton, 1996).
• Participants must have the presence of fixations in either the mortise joint, the subtalar joint or the tarsals (Brantingham et al, 2007).
• Participants that give informed consent to participate in the research.
• Participants on muscle relaxants or any anti inflammatory medication will be required to have a wash out period of three days before participating in the study (Poul et al, 1993; Seth, 1999).

You may not qualify if:

• Participants who have experienced an acute injury or acute re-injury (prior to or during the study) will be excluded from the study because it does not comply with the six-week interval (i.e. chronic injuries) (Pellow and Brantingham, 2001).
• Participants with balance disorders of a neurological and/or otological and/or vascular cause of dizziness that may mimic instability and defective proprioception at the ankle level (Clark and Burden, 2005; Kynsberg et al, 2006).
• Participants with connective tissue disorders that create excessive generalised ligamentous laxity, participants with these conditions will not benefit from the treatment with generalised hyper laxity of ligaments.
• Participants with grade three CAI/ gross mechanical instability of the lateral ankle complex as the severity of this grade of injury usually requires surgical intervention and is unresponsive to conservative therapy (Reid, 1992; Pellow and Brantingham, 2001; Rimando, 2008).Grade III: severe swelling and haemorrhage with positive anterior drawers sign and rupture of ligamentous structures.
• Participants that are contraindicated to adjustments, which include but may not be limited to (Kirkaldy - Willis and Burton, 1992).
• Absolute contraindications, Destructive injury of the skeletal structures of the body; fractures and dislocations of all varieties; neurological damage as in Cauda equina syndrome, abdominal aortic aneurysm, referred pain of a visceral nature.
• Relative Contraindications, bone demineralization, psychosomatic conditions, anticoagulant therapy and/or conditions where hemorrhaging may be present and Spondyloarthropathies.
• Participants with secondary manifestations of any of the following conditions, which may compromise balance/ proprioception, which are contraindicated to rehabilitation, which include and may not be limited to (Frontera, 1999).
• Dizziness that is present during the treatment Peripheral vascular disease

Sponsors & Collaborators

• Cleveland Chiropractic College: lead
• Durban University of Technology: collaborator

Study Sites (1)

Durban University of Technology

Durban, South Africa

RECRUITING

Related Publications (13)

• Ferran NA, Maffulli N. Epidemiology of sprains of the lateral ankle ligament complex. Foot Ankle Clin. 2006 Sep;11(3):659-62. doi: 10.1016/j.fcl.2006.07.002.

  PMID: 16971255 BACKGROUND

• Balint GP, Korda J, Hangody L, Balint PV. Regional musculoskeletal conditions: foot and ankle disorders. Best Pract Res Clin Rheumatol. 2003 Feb;17(1):87-111. doi: 10.1016/s1521-6942(02)00103-1.

  PMID: 12659823 BACKGROUND

• Delahunt, E. 2007. Neuromuscular contributions to functional instability of the ankle joint. Journal of Bodywork and Movement Therapies, 11:203-213.

  BACKGROUND

• Bozzelle, J.R. and Kishner, S. Recurrent Ankle Sprains. [Online] Available: http://emedicine.com, [Accessed August 2009].

  BACKGROUND

• Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.

  PMID: 16971246 BACKGROUND

• Reid, C.D. 1992. Sports Injury Assessment and Rehabilitation. United States of America: Churchill Livingston Inc

  BACKGROUND

• McBride DJ, Ramamurthy C. Chronic ankle instability: management of chronic lateral ligamentous dysfunction and the varus tibiotalar joint. Foot Ankle Clin. 2006 Sep;11(3):607-23. doi: 10.1016/j.fcl.2006.07.009.

  PMID: 16971252 BACKGROUND

• Caulfield, B. 2000. Functional Instability of the Ankle Joint, features and underlying causes. Physiotherapy, 86:8

  BACKGROUND

• Lee AJ, Lin WH. Twelve-week biomechanical ankle platform system training on postural stability and ankle proprioception in subjects with unilateral functional ankle instability. Clin Biomech (Bristol). 2008 Oct;23(8):1065-72. doi: 10.1016/j.clinbiomech.2008.04.013. Epub 2008 Jul 14.

  PMID: 18621453 BACKGROUND

• 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 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.

  PMID: 11174691 BACKGROUND

• Green T, Refshauge K, Crosbie J, Adams R. A randomized controlled trial of a passive accessory joint mobilization on acute ankle inversion sprains. Phys Ther. 2001 Apr;81(4):984-94.

  PMID: 11276181 BACKGROUND

• van der Wees PJ, Lenssen AF, Hendriks EJ, Stomp DJ, Dekker J, de Bie RA. Effectiveness of exercise therapy and manual mobilisation in ankle sprain and functional instability: a systematic review. Aust J Physiother. 2006;52(1):27-37. doi: 10.1016/s0004-9514(06)70059-9.

  PMID: 16515420 BACKGROUND

• Brantingham JW, Globe G, Pollard H, Hicks M, Korporaal C, Hoskins W. Manipulative therapy for lower extremity conditions: expansion of literature review. J Manipulative Physiol Ther. 2009 Jan;32(1):53-71. doi: 10.1016/j.jmpt.2008.09.013.

  PMID: 19121464 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• James W Brantingham, Dc, PhD

  Cleveland Chiropractic College

  PRINCIPAL INVESTIGATOR

• Danella Lubbe

  Durban University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James W Brantingham, DC, PhD

CONTACT

323.-906-2189; james.brantingham@cleveland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 27, 2010

Record last verified: 2010-09

Locations

ZA (1)