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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Cleveland Chiropractic College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Durban University of Technology South Africa
Information provided by:
Cleveland Chiropractic College
ClinicalTrials.gov Identifier:
NCT01196949
First received: September 7, 2010
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Chronic Ankle Instability
Other: Manipulative and Rehabilitative Therapy
Other: Rehabilitative Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Combined Manipulation and Rehabilitation Versus Rehabilitation Only, in the Management of Chronic Ankle Instability

Resource links provided by NLM:


Further study details as provided by Cleveland Chiropractic College:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: 3months ] [ Designated as safety issue: No ]
    Gold standard subjective pain scale


Secondary Outcome Measures:
  • Foot Ankle Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    General Ankle Function Assessment Tool


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manipulative and Rehabilitative Therapy Other: Manipulative and Rehabilitative Therapy
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.
Active Comparator: Rehabilitative Therapy Other: Rehabilitative Therapy
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.

Detailed Description:

Rationale

  1. Inversion ankle sprains are the most frequently encountered injury to the ankle (Ferran and Maffulli, 2006) especially in the realm of the sporting arena (Balint et al, 2003; Delahunt, 2007; Bozzelle and Kishner, 2008). Up to 40 % of these acutely injured participants will progress to a state of chronic ankle instability (CAI) (Verhagen et al, 1995; Balint et al, 2003; Ajis and Maffulli, 2006; Ajis et al, 2006). Therefore the lateral ankle as well as the management of CAI requires further investigation with regard to treatment options.
  2. Peroneal muscle weaknesses as well as proprioceptive deficits have been universally encountered in cases of CAI (Reid, 1992; Delahunt, 2007). Studies have indicated that coupled peroneal muscle strengthening and proprioception training of the ankle are seen as the most efficient means of rehabilitation for CAI (Reid, 1992; Ajis et al, 2006; Ajis and Maffulli, 2006; McBride and Ramamurthy, 2006; Caulfield, 2007; Lee and Lin, 2008). Pellow and Brantingham, (2001) and Gillman, (2004) have reported that manipulation is also a successful intervention tool for the treatment of CAI, documenting a statistically significant reduction in pain (p=0.007), improved range of motion (p=0.199) in the ankle joint as well as improved general functioning of the ankle (p=0.004). It has been identified that there are three components (Richie, 2001; Sefton et al, 2008) that contribute to the persistence of CAI namely joint fixations (in the mortise and subtalar joint) as well as muscular (Richie, 2001) and proprioceptive alterations (Richie, 2001; Delahunt, 2007).
  3. It is hypothesised 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 (Green et al, 2001; Eisenhart et al, 2003; Collins,2004; Vicenzino et al, 2006). There are insufficient studies, particularly high quality studies, with the required methodology, to make a definitive decision regarding whether this is supported (Van der Wees et al, 2006; Whitman et al, 2009). Additionally chiropractors will typically manage a participant with CAI with a combination of manipulation and rehabilitation, at present no research using such combined therapy by chiropractors has yet been published (Brantingham et al, 2009).

3. Research Problem and Aims The aim of the study is to investigate the relative effectiveness of a combination of manipulation and rehabilitation as compared to rehabilitation only in the treatment for CAI, in terms of participantive and objective clinical assessments.

The specific objectives of the study are:

  1. To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of objective assessments (algometer, berg balance scale, weight bearing ankle dorsiflexion test and foot and ankle disability index in participants experiencing CAI syndrome).
  2. To determine the relative effectiveness of manipulation and rehabilitation versus rehabilitation only, to the ankle joint in terms of participantive assessments (visual analogue scale and motion palpation) in participants experiencing CAI syndrome.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Participants between the ages of 18 - 45 years (Pellow and Brantingham, 2001; Chowdry et al, 2003; Parker, 2005).
  3. 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).
  4. 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).
  5. 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).
  6. Participants with a berg balance scale (Kornetti et al, 2004) of less than 45/56 to maintain homogeneity within the sample (Mouton, 1996).
  7. Participants must have the presence of fixations in either the mortise joint, the subtalar joint or the tarsals (Brantingham et al, 2007).
  8. Participants that give informed consent to participate in the research.
  9. 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).

Exclusion Criteria:

  1. 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).
  2. 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).
  3. 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.
  4. 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.
  5. 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196949

Contacts
Contact: James W Brantingham, DC, PhD 323.-906-2189 james.brantingham@cleveland.edu

Locations
South Africa
Durban University of Technology Recruiting
Durban, South Africa
Contact: Danella Lubbe       accounts@elconcranes.co.za   
Contact: Ekta Lakhani, MTech: Chiro       ektal@dut.ac.za   
Principal Investigator: Danella Lubbe         
Sponsors and Collaborators
Cleveland Chiropractic College
Durban University of Technology South Africa
Investigators
Principal Investigator: James W Brantingham, Dc, PhD Cleveland Chiropractic College
Principal Investigator: Danella Lubbe Durban University of Technology
  More Information

Publications:
Balint, G.P., Korda, J., Hangody, L., and Balint, P. 2003. Foot and Ankle disorders. Best practice and Research Clinical Rheumatology, 17:87-111
Delahunt, E. 2007. Neuromuscular contributions to functional instability of the ankle joint. Journal of Bodywork and Movement Therapies, 11:203-213.
Caulfield, B. 2000. Functional Instability of the Ankle Joint, features and underlying causes. Physiotherapy, 86:8

Responsible Party: James W. Brantingham, Cleveland Chiropractic College
ClinicalTrials.gov Identifier: NCT01196949     History of Changes
Other Study ID Numbers: CCC08132010A
Study First Received: September 7, 2010
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Chiropractic College:
Ankle
Chronic
Instability
Manipulative
Rehabilitative
Manipulation
Rehabilitation

ClinicalTrials.gov processed this record on April 17, 2014