Tennis ElbowNCT06674434
Comparative Effects of Sustained Stretch and Mobilization With Movement in Patient With Tennis Elbow
A study testing Mobilization with Movement and Sustained Stretch in people with Tennis Elbow and Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis
- What is being tested?
- Mobilization with Movement and Sustained Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow.
- The pain has persisted for at least 4 to 6 months.
- Individuals experience difficulty gripping and lifting objects due to elbow pain.
- Positive results were observed in both the Mills and Cozen tests.
Who cannot join
- Presence of nerve injuries or neuropathies in the arm or hand.
- No history of recent trauma or fracture to the elbow.
- No neurological conditions affecting the arm or hand
- Acute inflammation or signs of infection in the elbow joint.
- Presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Riphah Rehab center.
Lahore, Punjab Province, 54500
Ali Raza, aliraza@riphah.edu.pk
Laiba Manzoor, MS-OM
About this study
Official title: Comparative Effects of Sustained Stretch and Mobilization With Movement on Pain, Range of Motion, Muscle Strength and Functional Disability in Patient With Tennis Elbow.
Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. Various treatment options are available for this condition, with two notable methods being sustained stretching and Mobilization with Movement (MWM). Sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility. Conversely, MWM integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain. Muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities. Furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.
Read the detailed description
This randomized clinical trial will be conducted at Riphah Rehab center over duration of eight months. The sample size will consist of 58 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. 29 Participants will be assigned to Group A 29 to group B. Data will be collected using various assessment tools, including NPRS, ULFI, Universal Goniometer, Hand Held Dynamometer. Pre-intervention assessments will be conducted for groups. Data analysis will be performed by using SPSS 26 software.
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Being tested
- Mobilization with Movement, Sustained Stretch
- Keywords
- Lateral epicondylitis, Tennis Elbow, Sustained stretch, Mobilization with Movement, Muscle 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.
Mobilization with MovementOther
Mobilization with Movement (MWM) is a manual therapy technique that combines active, patient-directed movements with passive joint mobilization to treat tennis elbow. To find joint restrictions or dysfunctions, a comprehensive patient assessment is the first step in the process. While the patient was in a supine position with the elbow fully extended and the forearm pronated, the therapist applied a sustained lateral glide of the forearm and stabilized the distal portion of the arm. While the patient asked to make a fist, the therapist kept up the lateral glide. Each session included three sets of movement-based mobilizations, each with ten repetitions. The entire course of treatment consists of twelve sessions.
Sustained StretchOther
The basic concept of stretching involves lengthening the tendon during a state of relaxation. To stretch the Extensor Carpi Radialis Brevis tendon, the following position should be adopted: the elbow should be extended, the forearm in a pronated position, the wrist flexed, and the wrist should also be ulnar deviated, based on the patient's comfort level. This position should be maintained for 30 to 45 seconds and repeated three times before and after exercises in each treatment session, with a 30-second rest period in between.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The group will engage in traditional tennis elbow exercises and mobilization through movement. Receives: Other: Mobilization with Movement |
| Group B | Active comparator | The group will be given a prolonged stretch along with conventional tennis elbow exercises. Receives: Other: Sustained Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Numeric Pain Rating Scale (NPRS)
The most widely used pain rating scale, the Numeric Rating Scale (NPRS), has a range of 0 (no pain) to 10 (worst pain). The NPRS will be used to measure the degree of pain. For patients with tennis elbow, it will serve as an outcome measure. The NPRS is regarded as a valid, responsive, and dependable pain scale.
Measured: 4th week
Function: Upper Limb Functional Index (ULFI)
Twenty-five items on the ULFI measure how patients with ULMSDs perceive their own limitations in their activities. Three possible answers are provided for each item: "Yes" (1 point), "Partly" (0.5 points), and "No" (0 points). The maximum disability is determined by multiplying the total points (ranging from 0 to 25) by 4. The patient's functional score in relation to their maximum or pre-injury function is then calculated by subtracting this total score from 100 (0% represents maximum limitation, 100% represents normal or pre-injury function). The total rating can be calculated with no more than two missing responses.
Measured: 4th week
ROM: Universal Goniometer
A double-arm plastic goniometer with a semicircular scale is the most common goniometer for determining range of motion. We will measure the following wrist and elbow movements: wrist flexion, extension, radial and ulnar deviation, and elbow extension and pronation. Three measurements of each movement will be made, and the average will be computed for the outcome analysis.
Measured: 4th week
Strength: Handheld Dynamometer:
A handheld dynamometer (CAMRY EH 101 Electronic Handheld Dynamometer) was used to measure grip strength. The American Society of Hand Therapists' measurement protocols were modified to place participants in a high sitting position, maintain an elbow at a slight 40° flexion, and adjust the handle to the second position. After thoroughly explaining the procedure, the patient was instructed to exert the greatest amount of force possible on the handle and maintain that position for three to five seconds.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674434
- Sponsor's protocol ID
- REC/ RCR & AHS/24/0133
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karbowiak M, Holme T, Thambyrajah J, Di Mascio L. Management of lateral epicondylitis (tennis elbow). BMJ. 2023 May 18;381:e072574. doi: 10.1136/bmj-2022-072574. No abstract available.
PubMed 37201946Cutts S, Gangoo S, Modi N, Pasapula C. Tennis elbow: A clinical review article. J Orthop. 2019 Aug 10;17:203-207. doi: 10.1016/j.jor.2019.08.005. eCollection 2020 Jan-Feb.
PubMed 31889742Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
PubMed 33123709Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
PubMed 31543413Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
PubMed 32454922Kjaer M. Role of extracellular matrix in adaptation of tendon and skeletal muscle to mechanical loading. Physiol Rev. 2004 Apr;84(2):649-98. doi: 10.1152/physrev.00031.2003.
PubMed 15044685Pathan AF, Sharath HV. A Review of Physiotherapy Techniques Used in the Treatment of Tennis Elbow. Cureus. 2023 Oct 26;15(10):e47706. doi: 10.7759/cureus.47706. eCollection 2023 Oct.
PubMed 38021828Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
PubMed 31104005Girgis B, Duarte JA. Efficacy of physical therapy interventions for chronic lateral elbow tendinopathy: a systematic review. Physical Therapy Reviews. 2020;25(1):42-59.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Sustained Stretch and Mobilization With Movement on Pain, Range of Motion, Muscle Strength and Functional Disability in Patient With Tennis Elbow.
- ClinicalTrials.gov ID
- NCT06674434
- Acronym / sponsor ID
- REC/ RCR & AHS/24/0133
- Conditions
- Tennis Elbow, Lateral Epicondylitis
- Keywords
- Lateral epicondylitis, Tennis Elbow, Sustained stretch, Mobilization with Movement, Muscle strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Nov 2024 (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.
Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. Various treatment options are available for this condition, with two notable methods being sustained stretching and Mobilization with Movement (MWM). Sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility. Conversely, MWM integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain. Muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities. Furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.
Detailed description
This randomized clinical trial will be conducted at Riphah Rehab center over duration of eight months. The sample size will consist of 58 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. 29 Participants will be assigned to Group A 29 to group B. Data will be collected using various assessment tools, including NPRS, ULFI, Universal Goniometer, Hand Held Dynamometer. Pre-intervention assessments will be conducted for groups. Data analysis will be performed by using SPSS 26 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Mobilization with MovementThe group will engage in traditional tennis elbow exercises and mobilization through movement. |
| Group B | Active comparator | Other: Sustained StretchThe group will be given a prolonged stretch along with conventional tennis elbow exercises. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow.
- The pain has persisted for at least 4 to 6 months.
- Individuals experience difficulty gripping and lifting objects due to elbow pain.
- Positive results were observed in both the Mills and Cozen tests.
Key exclusion criteria (5 listed)
- Presence of nerve injuries or neuropathies in the arm or hand.
- No history of recent trauma or fracture to the elbow.
- No neurological conditions affecting the arm or hand
- Acute inflammation or signs of infection in the elbow joint.
- Presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases
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 |
|---|---|---|
| Mobilization with MovementMobilization with Movement (MWM) is a manual therapy technique that combines active, patient-directed movements with passive joint mobilization to treat tennis elbow. To find joint restrictions or dysfunctions, a comprehensive patient assessment is the first step in the process. While the patient was in a supine position with the elbow fully extended and the forearm pronated, the therapist applied a sustained lateral glide of the forearm and stabilized the distal portion of the arm. While the patient asked to make a fist, the therapist kept up the lateral glide. Each session included three sets of movement-based mobilizations, each with ten repetitions. The entire course of treatment consists of twelve sessions. | Other | Group A |
| Sustained StretchThe basic concept of stretching involves lengthening the tendon during a state of relaxation. To stretch the Extensor Carpi Radialis Brevis tendon, the following position should be adopted: the elbow should be extended, the forearm in a pronated position, the wrist flexed, and the wrist should also be ulnar deviated, based on the patient's comfort level. This position should be maintained for 30 to 45 seconds and repeated three times before and after exercises in each treatment session, with a 30-second rest period in between. | Other | Group B |
Primary outcome
Pain: Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
The most widely used pain rating scale, the Numeric Rating Scale (NPRS), has a range of 0 (no pain) to 10 (worst pain). The NPRS will be used to measure the degree of pain. For patients with tennis elbow, it will serve as an outcome measure. The NPRS is regarded as a valid, responsive, and dependable pain scale.
Function: Upper Limb Functional Index (ULFI)
Time frame: 4th week
Twenty-five items on the ULFI measure how patients with ULMSDs perceive their own limitations in their activities. Three possible answers are provided for each item: "Yes" (1 point), "Partly" (0.5 points), and "No" (0 points). The maximum disability is determined by multiplying the total points (ranging from 0 to 25) by 4. The patient's functional score in relation to their maximum or pre-injury function is then calculated by subtracting this total score from 100 (0% represents maximum limitation, 100% represents normal or pre-injury function). The total rating can be calculated with no more than two missing responses.
ROM: Universal Goniometer
Time frame: 4th week
A double-arm plastic goniometer with a semicircular scale is the most common goniometer for determining range of motion. We will measure the following wrist and elbow movements: wrist flexion, extension, radial and ulnar deviation, and elbow extension and pronation. Three measurements of each movement will be made, and the average will be computed for the outcome analysis.
Strength: Handheld Dynamometer:
Time frame: 4th week
A handheld dynamometer (CAMRY EH 101 Electronic Handheld Dynamometer) was used to measure grip strength. The American Society of Hand Therapists' measurement protocols were modified to place participants in a high sitting position, maintain an elbow at a slight 40° flexion, and adjust the handle to the second position. After thoroughly explaining the procedure, the patient was instructed to exert the greatest amount of force possible on the handle and maintain that position for three to five seconds.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 37201946Karbowiak M, Holme T, Thambyrajah J, Di Mascio L. Management of lateral epicondylitis (tennis elbow). BMJ. 2023 May 18;381:e072574. doi: 10.1136/bmj-2022-072574. No abstract available.
- Background: PubMed 31889742Cutts S, Gangoo S, Modi N, Pasapula C. Tennis elbow: A clinical review article. J Orthop. 2019 Aug 10;17:203-207. doi: 10.1016/j.jor.2019.08.005. eCollection 2020 Jan-Feb.
- Background: PubMed 33123709Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
- Background: PubMed 31543413Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
- Background: PubMed 32454922Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
- Background: PubMed 15044685Kjaer M. Role of extracellular matrix in adaptation of tendon and skeletal muscle to mechanical loading. Physiol Rev. 2004 Apr;84(2):649-98. doi: 10.1152/physrev.00031.2003.
- Background: PubMed 38021828Pathan AF, Sharath HV. A Review of Physiotherapy Techniques Used in the Treatment of Tennis Elbow. Cureus. 2023 Oct 26;15(10):e47706. doi: 10.7759/cureus.47706. eCollection 2023 Oct.
- Background: PubMed 31104005Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
- BackgroundGirgis B, Duarte JA. Efficacy of physical therapy interventions for chronic lateral elbow tendinopathy: a systematic review. Physical Therapy Reviews. 2020;25(1):42-59.
- 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.
Ali Raza, MS 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 Mobilization with Movement and Sustained Stretch in people with Tennis Elbow and 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674434, which also lists 9 linked publications.
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 5 Nov 2024.