- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484516
Effects of Eccentric Exercises Along With Muscle Energy Technique in Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lateral epicondylitis is one of the commonest reason of lateral elbow pain that affects 1-3% of the general population of middle-aged adults. A large population-based study of United States estimated its incidence as 3.4 cases per 1000 person annually with peak rates for 40-60 years old age group ranging between 7% and 10%.
Lateral epicondylitis (LE) or tennis elbow is simply a myotendinosis of the forearm extensor muscles that frequently associate with overuse injury due to repetitive strain by activities which impose excessive loads on common extensor tendinous origin at lateral epicondyle. Commonly this has been reported in those who engaged in activities which consist of repetitive wrist extension, radial deviation, gripping and/or forearm supination.
It leads to localized pain and tenderness at lateral epicondyle and along with the common extensor mass of the elbow making seemingly simple daily activities more difficult. This exaggerated with activities involving resisted wrist extension, middle finger extension, and forearm supination with extended elbow. The most common functional concern in LE is weak grip and restricted supination.
A vast number of physical therapy treatments such as different manual therapy techniques, exercise programs and modalities have been used. However eccentric training and manual therapy are the two most commonly used and beneficial physiotherapeutic treatment strategies.
Eccentric exercises have been suggested as first line treatment approach in conservative treatment as it improves overall function by lengthening the musculotendinous unit with low intensity load. It promotes healing and remodeling to increase collagen production and reduce pain by inhibiting pain neural pathways. Muscle energy technique (MET), a gentle manual therapy, is effective in addressing both myofascial issues and articular restrictions. It involves a patient's muscle contractions in a controlled position and direction against therapist's counterforce. Recently, international evidence supported its use in LE as a suitable intervention in this pathology and highlight its potential in reducing pain and improving grip and finger strength, and functionality in addition to home stretching and strengthening exercise.
Available literature in targeted population mainly evaluated effects of MET with other treatment techniques like corticosteroids, dry needling, movement with mobilization (MWM), friction massage etc. However, there is very limited literature available on using MET with eccentric exercise as a multimodal treatment for lateral epicondylitis which can point out whether using these two as a combination has better efficacy than alone. This manual therapy technique in combination of eccentric exercises, which has not been extensively studied in the context of lateral epicondylitis, can potentially enhance the therapeutic effects and provide new insights into the treatment and give more effective and tolerable strategy. So, the goal of this trial is to find effects of eccentric exercise along with MET as combined therapy in treating Lateral epicondylitis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Imran Amjad, PT, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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-
Sindh
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Karachi, Sindh, Pakistan, 75510
- Jinnah Post Graduate Medical Center (Orthopedic Workshop)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Subacute & chronic patients
Participants diagnosed with lateral epicondylitis based on
- Pain local to the lateral epicondyle reproduced with palpation.
- Positive Mill's test and Cozen's test and/or Maudsley's test
- Patient's willingness in participation in this study.
Exclusion Criteria:
• Any recent history of fracture /surgery
- Acute patients
- Peripheral nerve entrapment like radial tunnel syndrome
- Cervical radiculopathy
- Instability of joint
- Corticosteroid injection within 3- 6 months
- Neurological impairments
- Cardiovascular diseases
- Osteoporosis
- Local infection
- Malignancy
- Congenital /structural anomalies
- Systemic illness affecting joint function like Rheumatoid arthritis, psoriatic arthritis etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: Eccentric exercise along with muscle energy technique
Pulsed Ultrasound for 10 minutes, eccentric exercise and muscle energy technique for 8 sessions within 2 weeks.
|
For Eccentric Exercise, patient be in sitting position with full elbow extension, forearm pronation, and maximum wrist extension. The patient will be asked to slowly lower the wrist with 0.5 or 1 kg weight into flexion for a count of 30. Non-affected hand will be used to return the wrist to maximum extension again. 3 sets of 10 repetitions / session and 1 minute rest/set For MET, patient's affected forearm will be stabilized with 90 degrees flexed elbow. The mobilizing hand will hold the wrist and move into the supination until resistance or discomfort is detected. Then the patient will gently pronate against resistance for 5 seconds. Then with a relaxation phase of 5 seconds the therapist will stretch gently to re-position the forearm into a new supination barrier or until resistance will be met for several seconds (20-30 sec). No. of each isometric contraction in a single session will be 5 times. Pulsed mode ultrasound therapy will be given at frequency of I MHz for 10 minutes. |
|
Experimental: Group B: Muscle energy technique
Pulsed Ultrasound for 10 minutes and muscle energy technique for 8 sessions within 2 weeks.
|
For MET, patient's affected forearm will be stabilized with elbow 90 degrees flexed. The mobilizing hand will hold the wrist and move into the supination until resistance or discomfort is detected. Then the patient will gently pronate against resistance for 5 seconds. Then with a relaxation phase of 5 seconds the therapist will stretch gently to re-position the forearm into a new supination barrier or until resistance will be met for several seconds (20-30 sec). No of each isometric contraction in a single session will be 5 times. Pulsed mode ultrasound therapy will be given at frequency of I MHz for 10 minutes. |
|
Experimental: Group C: Eccentric exercise
Pulsed Ultrasound for 10 minutes and eccentric exercise for 8 sessions within 2 weeks.
|
For Eccentric Exercise Patient will be in sitting position with full elbow extension, forearm pronation, and maximum wrist extension. Then the patient will be asked to slowly lower wrist with 0.5 or 1 kg weight into flexion for a count of 30. Then they will use the non-affected hand to return the wrist to maximum extension again. 3 sets of 10 repetitions / session and 1 minute rest/set. Pulsed mode ultrasound therapy will be given at frequency of I MHz for 10 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: 2nd Week
|
Changes from Baseline pain values will be taken with the help of Numeric Pain Rating Scale measures level of pain.
Scoring is done by selecting a point from zero to ten as the current level of pain.
Zero means minimum pain and 10 denotes maximum pain.
|
2nd Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Rated Tennis Elbow Evaluation Scale
Time Frame: 2nd Week
|
Changes from Baseline functional disability value will be taken with the help of Patient Rated Tennis Elbow Evaluation Scale.
The PRTEE, a 15-item self-reported questionnaire, designed to measure patient's perceived pain and disability in Lower Extremity.
It consists of 5 items on pain scale, 10 items on function scale.
|
2nd Week
|
|
Pain-free grip strength
Time Frame: 2nd Week
|
Changes from Baseline pain-free grip strength will be measured by hand-held dynamometer (in Kg).
The amount of force that a patient can generate before any pain will be measured using a handgrip dynamometer and the mean of 3 successive trials will be used.
|
2nd Week
|
|
Range of Motion
Time Frame: 2nd Week
|
Changes from Baseline range of motion of wrist extension /flexion and forearm pronation/ supination will be taken with the help of universal goniometer.
|
2nd Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Muhammad Affan Iqbal, PT, PhD*, Riphah International University, Islamabad
- Principal Investigator: Dr. Saba Ramzan, PT, MSPT, Riphah International University, Islamabad
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPHAH/FR&AHS/Letter-014373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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