Lateral EpicondylitisNCT05698108
Effects Of Instrument Assisted Soft Tissue Mobilization on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis
A study testing Instrument Assisted Soft Tissue Mobilization (IASTM) and Conventional Physical Therapy in people with Lateral Epicondylitis and Tennis Elbow, run by University of Lahore at 1 site in Pakistan.
Trial summary
This study aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) using Ergon Tools on pain, grip strength and functional activity among patients diagnosed with Lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization (IASTM) and Conventional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 1 Nov 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Male and Female Patients
- Patients between the age group 20-50 years
- Sub-acute Patients having symptoms for > 6 weeks and < 3 months.
- Patients who had pain rating from 5 to 9 in VAS will be included
- Patients with Positive Cozens test, Mill's test
Who cannot join
- Patients with any surgical or trauma history of the elbow
- Rheumatoid Arthritis and Malignancies
- Cervical Radiculopathy patients who have referred pain in the elbow
- Loss of Passive ROM in extension
- Active infections such as, Bursitis, Calcification of the soft tissues, Fragile skin, Hyper Mobility \& Joint Effusion
- Hemophilic Patients
- Osteoporosis
- Patients with history of getting treatment with Steroid Injections will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sikander Medical Complex
Chak One Hundred Seventy-five Nine Left, Pujab, 52250
About this study
Official title: Effects Of Instrument Assisted Soft Tissue Mobilization Using Ergon Technique on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis: A Randomized Controlled Trial
This study aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) using Ergon Tools on pain, grip strength and functional activity among patients diagnosed with Lateral epicondylitis.
The study concluded that IASTM is effective in improving pain, grip strength and functional activity in patients with lateral epicondylitis.
Read the detailed description
Background: Lateral Epicondylitis is a type of "repetitive strain injury" that causes pain on the lateral portion of the elbow, especially while gripping and applying resistance to the forearm's extensor muscles, both men and women are equally affected by it. Traditional Physical Therapy has failed to improve the disorders caused by LE, Instrument Assisted Soft Tissue Mobilization is a new approach for its treatment a lot of tools are being used and Ergon Tools are among one of them, very less data is available for its efficacy in lateral epicondylitis patients.
Objective: To compare the effects of Instrument Assisted Soft Tissue Mobilization using Ergon Technique on pain, grip strength and functional activity in patients with lateral epicondylitis.
Methodology: 72 individuals with lateral epicondylitis pre-diagnosed by an orthopedic surgeon, are assessed from Sikander Medical Complex, Gujranwala. After fulfilling the inclusion criteria, the participants are randomly divided into two groups, 36 participants receiving IASTM using Ergon Tools and 36 participants received conventional physical therapy. Both groups receive treatment 2 times a week for 4 weeks. Outcome measures are pain (VAS), grip strength (handheld dynamometer), and functional mobility (PRTEE) collected at the baseline, 1st week, and 4th week.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Instrument Assisted Soft Tissue Mobilization (IASTM), Conventional Physical Therapy
- Keywords
- IASTM, Lateral Epicondylitis, tennis elbow, pain, grip strength, functional activity
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue Mobilization (IASTM)Device
Also called Ergon Tools
Tools designed for soft tissue mobilization
Conventional Physical TherapyOther
Also called Traditional Physical Therapy
Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physcial Therapy Group | Active comparator | All participants received treatment 2 times a week for 4 weeks. Pre-treatment included a Moist hot pack for 10 minutes and traditional physical therapy included Cyriax Deep Friction Massage (DFM), Ultrasound therapy as well as strengthening and stretching exercises Receives: Other: Conventional Physical Therapy |
| IASTM Group | Experimental | Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools. Receives: Device: Instrument Assisted Soft Tissue Mobilization (IASTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (mild to severe)
Visual Analogue Scale The score is calculated by measuring the distance (mm) between the "no pain" anchor and the patient's mark on a 10-cm line with a ruler, yielding a range of 0-100. A higher score implies that the pain is more intense and a lower score suggests the intensity of pain to be milder. VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain
Measured: 4 weeks
Grip Strength
Digital Hand Held Dynamometer The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort. The values listed below (in kg and lbs) give a guide to expected scores for adults. These values are the average of the best scores of each hand. See more Hand Grip Strength Norms. Other protocols will just use the score from the dominant hand, or compare the left and right hand results. See also examples of some actual athlete results.
Measured: 4 weeks
Functional Activity
Patient Rated Tennis Elbow Evaluation It consists of pain subscale and functional subscale, total score is calculated by adding Pain Subscale and Function Subscale then calculated as, Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)
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 posted26 Jan 2023
- Study start1 Mar 2022
- Primary completion30 Sep 2022
- Study completion1 Nov 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.
- 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
- Model description
- Randomized Controlled Trial
- 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
- Sponsor
- Investigators
- Shazal Nazir, DPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698108
- Sponsor's protocol ID
- ULahore Shazal Nazir
- Status last verified
- Jan 2023
- First submitted
- 26 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Instrument Assisted Soft Tissue Mobilization Using Ergon Technique on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05698108
- Acronym / sponsor ID
- ULahore Shazal Nazir
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- IASTM, Lateral Epicondylitis, tennis elbow, pain, grip strength, functional activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 26 Jan 2023 (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 aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) using Ergon Tools on pain, grip strength and functional activity among patients diagnosed with Lateral epicondylitis.
The study concluded that IASTM is effective in improving pain, grip strength and functional activity in patients with lateral epicondylitis.
Detailed description
Background: Lateral Epicondylitis is a type of "repetitive strain injury" that causes pain on the lateral portion of the elbow, especially while gripping and applying resistance to the forearm's extensor muscles, both men and women are equally affected by it. Traditional Physical Therapy has failed to improve the disorders caused by LE, Instrument Assisted Soft Tissue Mobilization is a new approach for its treatment a lot of tools are being used and Ergon Tools are among one of them, very less data is available for its efficacy in lateral epicondylitis patients.
Objective: To compare the effects of Instrument Assisted Soft Tissue Mobilization using Ergon Technique on pain, grip strength and functional activity in patients with lateral epicondylitis.
Methodology: 72 individuals with lateral epicondylitis pre-diagnosed by an orthopedic surgeon, are assessed from Sikander Medical Complex, Gujranwala. After fulfilling the inclusion criteria, the participants are randomly divided into two groups, 36 participants receiving IASTM using Ergon Tools and 36 participants received conventional physical therapy. Both groups receive treatment 2 times a week for 4 weeks. Outcome measures are pain (VAS), grip strength (handheld dynamometer), and functional mobility (PRTEE) collected at the baseline, 1st week, and 4th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Physcial Therapy Group | Active comparator | Other: Conventional Physical TherapyAll participants received treatment 2 times a week for 4 weeks. Pre-treatment included a Moist hot pack for 10 minutes and traditional physical therapy included Cyriax Deep Friction Massage (DFM), Ultrasound therapy as well as strengthening and stretching exercises |
| IASTM Group | Experimental | Device: Instrument Assisted Soft Tissue Mobilization (IASTM)Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both Male and Female Patients
- Patients between the age group 20-50 years
- Sub-acute Patients having symptoms for > 6 weeks and < 3 months.
- Patients who had pain rating from 5 to 9 in VAS will be included
- Patients with Positive Cozens test, Mill's test
Key exclusion criteria (8 listed)
- Patients with any surgical or trauma history of the elbow
- Rheumatoid Arthritis and Malignancies
- Cervical Radiculopathy patients who have referred pain in the elbow
- Loss of Passive ROM in extension
- Active infections such as, Bursitis, Calcification of the soft tissues, Fragile skin, Hyper Mobility \& Joint Effusion
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 |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization (IASTM)Also: Ergon ToolsTools designed for soft tissue mobilization | Device | IASTM Group |
| Conventional Physical TherapyAlso: Traditional Physical TherapyMoist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises. | Other | Conventional Physcial Therapy Group |
Primary outcome
Pain (mild to severe)
Time frame: 4 weeks
Visual Analogue Scale The score is calculated by measuring the distance (mm) between the "no pain" anchor and the patient's mark on a 10-cm line with a ruler, yielding a range of 0-100. A higher score implies that the pain is more intense and a lower score suggests the intensity of pain to be milder. VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain
Grip Strength
Time frame: 4 weeks
Digital Hand Held Dynamometer The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort. The values listed below (in kg and lbs) give a guide to expected scores for adults. These values are the average of the best scores of each hand. See more Hand Grip Strength Norms. Other protocols will just use the score from the dominant hand, or compare the left and right hand results. See also examples of some actual athlete results.
Functional Activity
Time frame: 4 weeks
Patient Rated Tennis Elbow Evaluation It consists of pain subscale and functional subscale, total score is calculated by adding Pain Subscale and Function Subscale then calculated as, Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)
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 26 Jan 2023.
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Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
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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.
Shazal Nazir, DPT principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization (IASTM) and Conventional Physical Therapy in people with Lateral Epicondylitis and Tennis Elbow, 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 5 inclusion and 8 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 26 Jan 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 (mild to severe) (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 26 Jan 2023.