Lateral EpicondylitisNCT05070559
Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis
A study testing Active Release Technique and Graston Technique Group in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 36 participants will be taken. Patients will be divided into two groups by sealed envelop method. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Active Release Technique and Graston Technique Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 16 Feb 2022
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chronic lateral epicondylitis, complaints for at least 3 months or more
- Pain intensity level between 3 to 6 on 0-10 point numerical pain rating scale
Who cannot join
- Acute/ sub-acute lateral epicondylitis
- Any cervical spine or any other upper limb dysfunction
- Any other neurological disease, cardiovascular disease, osteoporosis
- Bilateral complaints
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawal General Hospital Rawalpindi
Rawalpindi, Punjab Province, 44000
About this study
Official title: Comparison of Active Release Technique and Graston Technique In Patients With Chronic Lateral Epicondylitis
This study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 36 participants will be taken. Patients will be divided into two groups by sealed envelop method. Patients in group A will receive Active Release Technique along with conventional therapy while Patients in group B will receive instrument assisted soft tissue mobilization along with conventional therapy. The study includes intervention protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. The outcome measures Numeric pain rating scale(NPRS), Hand Dynamometer and Patient-Rated Tennis Elbow Evaluation (PRTEE) will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25
Read the detailed description
Lateral epicondylitis is an injury caused by overusing the elbow. It is characterized by tenderness and pain over the lateral epicondyle of the elbow. It is not exactly a condition involving inflammation rather a chronic degeneration of the tendon. The major symptom of lateral epicondylitis is presentation or complaint of sharp pain at the lateral side of the elbow with swelling
- Conditions
- Lateral Epicondylitis
- Being tested
- Active Release Technique, Graston Technique Group
- Keywords
- lateral Epicondylitis, Graston Technique, Active Release Technique, Grip Strength
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Release TechniqueOther
Patients in this group will receive Active Release Technique along with conventional therapy. ART will be given with patient seated, elbow flexed and resting on the treatment table, forearm in midprone \& wrist in neutral position and then the therapist will work on the common extensor tendon by applying pressure to the tendon distal to their attachment at the elbow. The patient will start with the elbow bent and wrist straight. As the therapist hold the muscles, the patient will extend the elbow and pronate and flex the wrist while the therapist move the pressure proximally, attempting to release adhesions around and between muscle planes. Total of 15 repetitions for of 10 minutes.
CONVENTIONAL THERAPY:
- Hot pack for 15 minutes
- TENS for 15 minutes
- Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)
Graston Technique GroupOther
Patients in this group will receive IASTM along with conventional therapy. In graston technique proper application of GT3 which include application of a cream to the common extensor tendon. The GT3will be then used to common extensor tendon. In areas of increased tissue restriction, more required pressure with GT3 is applied using increased force and shorter strokes over the areas of restriction. Ice will be offered as needed for pain management after each session.
The study includes interventional protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks.
CONVENTIONAL THERAPY:
- Hot pack for 15 minutes
- TENS for 15 minutes
- Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Active Release Technique Group | Experimental | Patients in this group will receive Active Release Technique along with conventional therapy Receives: Other: Active Release Technique |
| Graston Technique Group | Experimental | Patients in this group will receive Instrumental Assisted Soft Tissue Mobilization along with conventional therapy Receives: Other: Graston Technique Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale that is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.
Measured: 4 Weeks
Hand Dynamometer
hand dynamometer is the most reliable and acceptable tool for measuring grip strength. It detects and quantitatively determines the degree of weak grip strength. (ICC = 0.99)
Measured: 4 Weeks
Patient-Rated Tennis Elbow Evaluation
The Patient-Rated Tennis Elbow Evaluation questionnaire is a specific questionnaire available for assessing the functional status of patients with lateral epicondylitis. (ICC = 0.96)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Nov 2021
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sajjad Ali, Ms-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070559
- Sponsor's protocol ID
- Iqra Shabbir
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active Release Technique and Graston Technique In Patients With Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05070559
- Acronym / sponsor ID
- Iqra Shabbir
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral Epicondylitis, Graston Technique, Active Release Technique, Grip Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 7 Oct 2021 (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.
This study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 36 participants will be taken. Patients will be divided into two groups by sealed envelop method. Patients in group A will receive Active Release Technique along with conventional therapy while Patients in group B will receive instrument assisted soft tissue mobilization along with conventional therapy. The study includes intervention protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. The outcome measures Numeric pain rating scale(NPRS), Hand Dynamometer and Patient-Rated Tennis Elbow Evaluation (PRTEE) will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25
Detailed description
Lateral epicondylitis is an injury caused by overusing the elbow. It is characterized by tenderness and pain over the lateral epicondyle of the elbow. It is not exactly a condition involving inflammation rather a chronic degeneration of the tendon. The major symptom of lateral epicondylitis is presentation or complaint of sharp pain at the lateral side of the elbow with swelling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Release Technique Group | Experimental | Other: Active Release TechniquePatients in this group will receive Active Release Technique along with conventional therapy |
| Graston Technique Group | Experimental | Other: Graston Technique GroupPatients in this group will receive Instrumental Assisted Soft Tissue Mobilization along with conventional therapy |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Chronic lateral epicondylitis, complaints for at least 3 months or more
- Pain intensity level between 3 to 6 on 0-10 point numerical pain rating scale
Key exclusion criteria (4 listed)
- Acute/ sub-acute lateral epicondylitis
- Any cervical spine or any other upper limb dysfunction
- Any other neurological disease, cardiovascular disease, osteoporosis
- Bilateral complaints
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 |
|---|---|---|
| Active Release TechniquePatients in this group will receive Active Release Technique along with conventional therapy. ART will be given with patient seated, elbow flexed and resting on the treatment table, forearm in midprone \& wrist in neutral position and then the therapist will work on the common extensor tendon by applying pressure to the tendon distal to their attachment at the elbow. The patient will start with the elbow bent and wrist straight. As the therapist hold the muscles, the patient will extend the elbow and pronate and flex the wrist while the therapist move the pressure proximally, attempting to release adhesions around and between muscle planes. Total of 15 repetitions for of 10 minutes. CONVENTIONAL THERAPY: * Hot pack for 15 minutes * TENS for 15 minutes * Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes) | Other | Active Release Technique Group |
| Graston Technique GroupPatients in this group will receive IASTM along with conventional therapy. In graston technique proper application of GT3 which include application of a cream to the common extensor tendon. The GT3will be then used to common extensor tendon. In areas of increased tissue restriction, more required pressure with GT3 is applied using increased force and shorter strokes over the areas of restriction. Ice will be offered as needed for pain management after each session. The study includes interventional protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. CONVENTIONAL THERAPY: * Hot pack for 15 minutes * TENS for 15 minutes * Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes) | Other | Graston Technique Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 Weeks
The Numeric Pain Rating Scale that is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.
Hand Dynamometer
Time frame: 4 Weeks
hand dynamometer is the most reliable and acceptable tool for measuring grip strength. It detects and quantitatively determines the degree of weak grip strength. (ICC = 0.99)
Patient-Rated Tennis Elbow Evaluation
Time frame: 4 Weeks
The Patient-Rated Tennis Elbow Evaluation questionnaire is a specific questionnaire available for assessing the functional status of patients with lateral epicondylitis. (ICC = 0.96)
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 18 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Sajjad Ali, Ms-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Release Technique and Graston Technique Group in people with Lateral Epicondylitis, run by Riphah International University 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 2 inclusion and 4 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 18 Apr 2022. 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?
Numeric Pain Rating Scale (time frame: 4 Weeks). 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 18 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.