Achilles TendonitisNCT05550857
Effect of Myofacial Release vs. Eccentric Resistance on Pain, ROM and Functional Disability on Achilles Tendonitis
A study testing eccentric resistance exercise and myofascial release in people with Achilles Tendonitis, run by University of Lahore at 1 site in Pakistan.
Trial summary
Achilles tendinitis is a common condition that cause pain along back of leg near the heal. It is an overuse injury of the Achilles tendon, the band of tissue that connect calf muscles at the back of the lower leg to heel bone. There are number of treatment approaches to relieve pain in Achilles tendonitis . Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Achilles Tendonitis
- What is being tested?
- eccentric resistance exercise and myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female.
- Age limit 25-50 year.
- Diagnosed patients by orthopedic surgeon.
- Achilles tendon symptoms (pain) present in one limb for a minimum of two months.
- Report having pain rated at least 3 out of 10 on a numerical rating scale (NRS-11).
- Be able to walk household distances (more than 50 m) without the aid of a walker, crutches or can
Who cannot join
- History of Pregnanc.
- Having history of rheumatoid arthritis or generalized polyarthritis.
- Pervious history of Achilles tendon rupture or surgery i.e arthrodesis , club foot surgery
- History of hind foot fracture, or leg-length discrepancy of more than one-half inch.
- Taken any manual therapy in last 3 month.
- Contraindication to myofacial releas i.e skin burn or disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Myofacial Release With and Without Eccentric Resistance on Pain, Range of Motion and Functional Disability in Patients With Achilles Tendonitis
Achilles tendinitis is a common condition that cause pain along back of leg near the heal. It is an overuse injury of the Achilles tendon, the band of tissue that connect calf muscles at the back of the lower leg to heel bone. There are number of treatment approaches to relieve pain in Achilles tendonitis . Insufficient literature has discuss the combine effect of myofascial release with eccentric resistance. So the aim of the study is to compare the effect of myofascial release with eccentric resistance and without eccentric resistance on pain , range of motion and functional disability in patient with Achilles tendinitis
Read the detailed description
Tendonitis refers to inflammation of a tendon in response to injury or disease. It causes pain, irritation, and swelling, especially following periods of activity. Achilles tendinitis (AT) is a prevalent condition across the lifespan in both active and sedentary people, and can occur in the mid tendon, tendon insertion to the calcaneus and peritendon.
Achilles tendinitis is caused by overuse of the ankle and is closely related to an individuals activity level. In the adult population (21-60 yrs old), the incidence rate is 2.35 persons per 1000. It has been reported in approximately 7%-9% of professional athletes and 6%-18% of regular runners.
People with Achilles tendinitis typically report symptoms of pain and stiffness upon weight bearing after prolonged rest and at the start of physical activity, which reduces as the activity continues . These symptoms lead to impaired performance. In more severe cases, pain and disability can be persistent with functional activities such as walking.
Physical therapists have used different methods to maintain and also to increase joint motion, and prevent deformity and dysfunction resulting from the muscle shortening. The intension of the physical therapist is to lengthen the musculo-tendinous unit, supporting connective tissue and increase the range of motion.
Soft tissue treatments are widely used for AT, but strong scientific evidence to support those treatments is lacking. The literature provides some evidence that heavy pressure and deep massage might have some positive effect on chronic tendonitis by promoting healing.
Eccentric training can be effective in the rehabilitation of patients with Achilles tendonitis. The mechanism behind these results is not clear. However, there is evidence that tendons are able to respond to repeated forces by altering their structure and composition, and, thus, their mechanical properties change
- Conditions
- Achilles Tendonitis
- Being tested
- eccentric resistance exercise, myofascial release
- Keywords
- Physiotherapy ,, Myofascial release, Eccentric Resistance, Achilles tendonitis, Pain, Range of motion, Functional Disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eccentric resistance exerciseOther
The subject will lying prone on a treatment table. One end of eccentric resistance band will tie around the mid of the foot of indvidual, the other end of the resistance band will be attach to the table and the band is adjusted so that it will tight and there will be no slack present in it. It will provide a smooth eccentric resistance throughout the dorsiflexion range
myofascial releaseOther
The subject will lye prone on a treatment table. Deep longitudinal massage with the help of both thumbs reinforcing eachother will be given on the subject's calf muscles.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release | Active comparator | Group A:
This group will receive routine physiotherapy with myofascial release. This protocol will be given for 3 alternative days per week. Each session will be of 45 minutes. Data will be collected at baseline, at 2nd week and at 4th week. Receives: Other: myofascial release |
| eccentric resistance exercise | Experimental | Group B:
This group will receive routine physiotherapy and myofascial release with eccentric resistance exercise . This protocol will be given for 3 alternative days per week. Each session will be of 60 minutes. Data will be collected at baseline, at 2nd week and at 4th week. Receives: Other: eccentric resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain intensity will be measured by Numeric Pain Rating Scale
Measured: change in pain intensity score will be measured at baseline , at 2nd week , at 4th week
Range of motion
Range of motion will be measured by goniometer
Measured: Change in range of motion score will be measured at baseline , at 2nd week , at 4th week
Functional disability
Functional disability will be measured by ankle foot disability index
Measured: change in Function disability score will be measured at baseline, at 2nd week , at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start19 Sep 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendonitisStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550857
- Sponsor's protocol ID
- Muhammad sufyan karamat
- Status last verified
- Apr 2023
- First submitted
- 19 Sep 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immediately after publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Myofacial Release With and Without Eccentric Resistance on Pain, Range of Motion and Functional Disability in Patients With Achilles Tendonitis
- ClinicalTrials.gov ID
- NCT05550857
- Acronym / sponsor ID
- Muhammad sufyan karamat
- Conditions
- Achilles Tendonitis
- Keywords
- Physiotherapy ,, Myofascial release, Eccentric Resistance, Achilles tendonitis, Pain, Range of motion, Functional Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Achilles tendinitis is a common condition that cause pain along back of leg near the heal. It is an overuse injury of the Achilles tendon, the band of tissue that connect calf muscles at the back of the lower leg to heel bone. There are number of treatment approaches to relieve pain in Achilles tendonitis . Insufficient literature has discuss the combine effect of myofascial release with eccentric resistance. So the aim of the study is to compare the effect of myofascial release with eccentric resistance and without eccentric resistance on pain , range of motion and functional disability in patient with Achilles tendinitis
Detailed description
Tendonitis refers to inflammation of a tendon in response to injury or disease. It causes pain, irritation, and swelling, especially following periods of activity. Achilles tendinitis (AT) is a prevalent condition across the lifespan in both active and sedentary people, and can occur in the mid tendon, tendon insertion to the calcaneus and peritendon.
Achilles tendinitis is caused by overuse of the ankle and is closely related to an individuals activity level. In the adult population (21-60 yrs old), the incidence rate is 2.35 persons per 1000. It has been reported in approximately 7%-9% of professional athletes and 6%-18% of regular runners.
People with Achilles tendinitis typically report symptoms of pain and stiffness upon weight bearing after prolonged rest and at the start of physical activity, which reduces as the activity continues . These symptoms lead to impaired performance. In more severe cases, pain and disability can be persistent with functional activities such as walking.
Physical therapists have used different methods to maintain and also to increase joint motion, and prevent deformity and dysfunction resulting from the muscle shortening. The intension of the physical therapist is to lengthen the musculo-tendinous unit, supporting connective tissue and increase the range of motion.
Soft tissue treatments are widely used for AT, but strong scientific evidence to support those treatments is lacking. The literature provides some evidence that heavy pressure and deep massage might have some positive effect on chronic tendonitis by promoting healing.
Eccentric training can be effective in the rehabilitation of patients with Achilles tendonitis. The mechanism behind these results is not clear. However, there is evidence that tendons are able to respond to repeated forces by altering their structure and composition, and, thus, their mechanical properties change
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial release | Active comparator | Other: myofascial releaseGroup A: This group will receive routine physiotherapy with myofascial release. This protocol will be given for 3 alternative days per week. Each session will be of 45 minutes. Data will be collected at baseline, at 2nd week and at 4th week. |
| eccentric resistance exercise | Experimental | Other: eccentric resistance exerciseGroup B: This group will receive routine physiotherapy and myofascial release with eccentric resistance exercise . This protocol will be given for 3 alternative days per week. Each session will be of 60 minutes. Data will be collected at baseline, at 2nd week and at 4th week. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and female.
- Age limit 25-50 year.
- Diagnosed patients by orthopedic surgeon.
- Achilles tendon symptoms (pain) present in one limb for a minimum of two months.
- Report having pain rated at least 3 out of 10 on a numerical rating scale (NRS-11).
Key exclusion criteria (6 listed)
- History of Pregnanc.
- Having history of rheumatoid arthritis or generalized polyarthritis.
- Pervious history of Achilles tendon rupture or surgery i.e arthrodesis , club foot surgery
- History of hind foot fracture, or leg-length discrepancy of more than one-half inch.
- Taken any manual therapy in last 3 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eccentric resistance exerciseThe subject will lying prone on a treatment table. One end of eccentric resistance band will tie around the mid of the foot of indvidual, the other end of the resistance band will be attach to the table and the band is adjusted so that it will tight and there will be no slack present in it. It will provide a smooth eccentric resistance throughout the dorsiflexion range | Other | eccentric resistance exercise |
| myofascial releaseThe subject will lye prone on a treatment table. Deep longitudinal massage with the help of both thumbs reinforcing eachother will be given on the subject's calf muscles. | Other | Myofascial release |
Primary outcome
pain intensity
Time frame: change in pain intensity score will be measured at baseline , at 2nd week , at 4th week
pain intensity will be measured by Numeric Pain Rating Scale
Range of motion
Time frame: Change in range of motion score will be measured at baseline , at 2nd week , at 4th week
Range of motion will be measured by goniometer
Functional disability
Time frame: change in Function disability score will be measured at baseline, at 2nd week , at 4th week
Functional disability will be measured by ankle foot disability index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Yes. Immediately after publication
Related trials for Achilles Tendonitis
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Not yet recruitingObservational study
CUHK Achilles Tendon Disorder Registry
Achilles Tendon Injury, Achilles Tendon
RecruitingObservational study
Zadek Osteotomy for Treatment of Haglund's Syndrome
Haglund's Disease
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eccentric resistance exercise and myofascial release in people with Achilles Tendonitis, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: change in pain intensity score will be measured at baseline , at 2nd week , at 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.