NCT01225497

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 21, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

October 18, 2010

Last Update Submit

October 20, 2010

Conditions

Achilles TendonTendinopathy

Keywords

RandomizedPilot studyVISA-AVAS

Outcome Measures

Primary Outcomes (3)

  • Victorian Institute of Sports Assessment-Achilles (VISA-A)

    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.

    Baseline

  • Victorian Institute of Sports Assessment-Achilles (VISA-A)

    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.

    Week 3

  • Victorian Institute of Sports Assessment-Achilles (VISA-A)

    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.

    Week 6

Secondary Outcomes (4)

  • Visual Analogue Scale

    Baseline

  • Participant satisfaction

    Week 6

  • Visual Analogue Scale

    Week 3

  • Visual Analogue Scale

    Weeks 6

Study Arms (2)

Standard eccentric exercise

ACTIVE COMPARATOR

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

Eccentric exercise as able

EXPERIMENTAL

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

Interventions

Standard eccentric exercisePROCEDURE

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.

Standard eccentric exercise
Eccentric exercise-Experimental groupPROCEDURE

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.

Eccentric exercise as able

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age
  • Ability to give informed written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Forth Valley

Falkirk, FK1 2 AU, United Kingdom

Location

Related Publications (4)

  • Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.

    PMID: 9617396BACKGROUND

  • Rompe JD, Furia JP, Maffulli N. Mid-portion Achilles tendinopathy--current options for treatment. Disabil Rehabil. 2008;30(20-22):1666-76. doi: 10.1080/09638280701785825.

    PMID: 18608388BACKGROUND

  • Roos EM, Engstrom M, Lagerquist A, Soderberg B. Clinical improvement after 6 weeks of eccentric exercise in patients with mid-portion Achilles tendinopathy -- a randomized trial with 1-year follow-up. Scand J Med Sci Sports. 2004 Oct;14(5):286-95. doi: 10.1111/j.1600-0838.2004.378.x.

    PMID: 15387802BACKGROUND

  • Ohberg L, Lorentzon R, Alfredson H. Eccentric training in patients with chronic Achilles tendinosis: normalised tendon structure and decreased thickness at follow up. Br J Sports Med. 2004 Feb;38(1):8-11; discussion 11. doi: 10.1136/bjsm.2001.000284.

    PMID: 14751936BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Marc Stevens, B.Sc (Hons)

    Queen Margaret University/NHS Forth Valley

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Stevens, B.Sc (Hons)

CONTACT

441786 434061marc.stevens@nhs.net

Frank Gilroy, M.Sc

CONTACT

441786 434061frank.gilroy@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 21, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 21, 2010

Record last verified: 2010-09

Locations

GB(1)