Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Queen Margaret University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Queen Margaret University
ClinicalTrials.gov Identifier:
NCT01225497
First received: October 18, 2010
Last updated: October 20, 2010
Last verified: September 2010
  Purpose

Chronic pain and disability are unfortunately common in Achilles tendon pain. Outcome after surgery is often poor. Also tendon pain can be resistant to treatment and may lead to cessation of hobbies or careers.

Recently eccentric exercise (defined as muscle loading where tension develops as physical lengthening occurs) has become a cornerstone in managing tendon pain due to an increasing amount of favorable research. Eccentric exercises are considered to be non-invasive, safe, and appear to be important for a successful outcome.

One exercise program has been extensively adopted in research and clinical practice for Achilles pain. It recommends individuals perform 180 repetitions a day. However there appears to be little scientific rationale for this number. Consequently there may be significant implications for patient compliance, satisfaction, and overall treatment efficacy in a strategy which is encouraged to be uncomfortable.

Fifty two adults (18-70 years old), with mid-Achilles tendon pain will be randomised to standard treatment (180 repetitions) or to a group where individuals are allowed to do what they can. Participants will be recruited from participating physiotherapy departments (health centres and hospital departments) across NHS Forth Valley. All individuals will be required to complete the same type of eccentric exercise for six weeks attending an initial assessment and two follow-up appointments at three and six weeks. Thereafter participants will be discharged if better, or continue with individual care where appropriate.

It is hoped this pilot study will establish if future larger scale investigation is warranted examining whether it is necessary to subject individuals to 180 repetitions a day in an activity recommended to be uncomfortable. Also will participant satisfaction differ between exercise groups? If further investigation is warranted this pilot may provide population specific data for future sample size calculations, and may provide a suitable methodology for such investigations.


Condition Intervention
Achilles Tendon
Tendinopathy
Procedure: Standard eccentric exercise
Procedure: Eccentric exercise-Experimental group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Two Eccentric Exercise Protocols on Reported Pain Intensity, Function, and Treatment Satisfaction in Adults With Chronic Mid-portion Achilles Tendinopathies

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • Victorian Institute of Sports Assessment-Achilles (VISA-A) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.

  • Victorian Institute of Sports Assessment-Achilles (VISA-A) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.

  • Victorian Institute of Sports Assessment-Achilles (VISA-A) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The VISA-A is has been reported as a valid and reliable measure for determining the extent of functional limitation in individuals suffering Achilles tendon pain. It has been recommended for use in reseach evaluating Achilles tendon pain. It is a questionnaire which gives a score out of 100 with higher scores indicating increasing levels of disability.


Secondary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This is being utilised in this study to give an indication of the level of intensity of pain an individual with Achilles pain. Participants will make a mark on a 100mm horizontal line to indicate the intensity of their pain.

  • Participant satisfaction [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Simple Likert style descriptors will be used (Poor, moderate, good, excellent).

  • Visual Analogue Scale [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    This is being utilised in this study to give an indication of the level of intensity of pain an individual with Achilles pain. Participants will make a mark on a 100mm horizontal line to indicate the intensity of their pain.

  • Visual Analogue Scale [ Time Frame: Weeks 6 ] [ Designated as safety issue: No ]
    This is being utilised in this study to give an indication of the level of intensity of pain an individual with Achilles pain. Participants will make a mark on a 100mm horizontal line to indicate the intensity of their pain.


Estimated Enrollment: 52
Study Start Date: November 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard eccentric exercise
Participants randomised to this group shall complete 180 repetitions a day of Alfredsons heel drop protocol. This has been accepted as standard management for mid-portion Achilles pain in the first instance.
Procedure: Standard eccentric exercise

Participants stand with the balls of their feet on a step. They rise up onto tip toes using both legs then transfer onto the affected leg, then slowly lower their heel below the level of the step keeping their weight-bearing limb fully straight (eccentric phase). This constitutes 1 repetition and is repeated for 3 x 15 reps.

The previous procedure is then carried out with the knee bent during the eccentric phase of loading for 3 x 15 reps.

All of the above is carried out twice a day as per Alfredsons protocol. Participants are encouraged as per Alfredsons procedure to continue into discomfort not severe pain.

Experimental: Eccentric exercise as able
Participants randomised to this group shall carry out exactly the same eccentric exercises as per Alfredsons heel drop protocol. However, these individuals will be instructed to do what they can.
Procedure: Eccentric exercise-Experimental group
Eccentric exercise is performed the same as in the standard group. However participants in this group are encouraged to do the number of repetition they can manage so long as it is also to discomfort.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mid-portion Achilles tenderness on palpation or during/after activity 2-7cm proximal to insertion of a month or more duration
  • Wish to return to previous level of function
  • Tendon thickening 2-7cm proximal to insertion may or may not be present. Although associated with Achilles tendinopathies it is not required for diagnosis
  • 18-70 years of age
  • Ability to give informed written consent

Exclusion Criteria:

  • Indeterminate diagnosis
  • Tendon insertion pain
  • Recent fracture of the affected lower limb (within the last 12 months)
  • Presence of bursitis
  • Less than one month of symptoms
  • Previous surgical intervention near the Achilles tendon (within the last 12 months)
  • Previous experience of eccentric loading
  • Sudden onset of symptoms suggesting partial rupture rather than tendinopathy
  • Previous tendon rupture
  • Steroid injection near the Achilles tendon in the last month
  • Presence of rheumatoid arthritis, diabetes, or other systemic disorders; radiculopathy etc. that could significantly contribute to posterior ankle pain
  • Congenital or acquired deformities of the knee or ankle
  • Inability to complete eccentric exercises
  • Inability to understand spoken or written English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225497

Contacts
Contact: Marc Stevens, B.Sc (Hons) 441786 434061 marc.stevens@nhs.net
Contact: Frank Gilroy, M.Sc 441786 434061 frank.gilroy@nhs.net

Locations
United Kingdom
NHS Forth Valley Not yet recruiting
Falkirk, United Kingdom, FK1 2 AU
Contact: Marc Stevens, B.Sc    441786 434061    marc.stevens@nhs.net   
Principal Investigator: Marc Stevens, B.Sc         
Sponsors and Collaborators
Queen Margaret University
Investigators
Principal Investigator: Marc Stevens, B.Sc (Hons) Queen Margaret University/NHS Forth Valley
  More Information

Publications:
Responsible Party: Mr Marc Stevens/Highly Specialist Physiotherapist, NHS Forth Valley / Queen Margaret University
ClinicalTrials.gov Identifier: NCT01225497     History of Changes
Other Study ID Numbers: FV526
Study First Received: October 18, 2010
Last Updated: October 20, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Margaret University:
Randomized
Pilot study
VISA-A
VAS

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014