Lateral EpicondylitisNCT06500585
Effects of Mill's Manipulation Along With Muscle Energy Technique in Lateral Epicondylitis
A study testing Mill's Manipulation and Mill's Manipulation and Muscle Energy Technique in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The effects of Muscle Energy Technique intervention have been investigated in recent studies in Lateral Epicondylitis. Some studies have been conducted about mills manipulation and Muscle Energy Technique but according to the literature review there is no study exist to determine the effects of Mill's Manipulation… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Mill's Manipulation and Mill's Manipulation and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Oct 2023to 30 Jun 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient that have been diagnosed with lateral epicondylitis (pain and point tenderness over lateral epicondyle and / or 1-2cm distal to epicondyle).
- Both male and female patients between the age group of 18 to 45 years old.
- Any of the following tests positive: Cozen Test, Mills, Maudsley.
Who cannot join
- History of rheumatic arthritis
- History of elbow instability
- History of former fracture of the elbow
- History of cervical radiculopathy.
- History of radial tunnel syndrome (Patient with RTS will report pain over lateral forearm approximately 3 to 5 cm distal to the elbow worsens with rotational movements of the forearm).
- History of any neoplasia
Show all 10Show fewer
- Any congenital or acquired deformity of upper limb.
- History of trauma.
- History of Corticosteroid injection within 6 months.
- Individual having symptoms of vertigo
Trial locations and contacts
1 site in 1 country.
About this study
The effects of Muscle Energy Technique intervention have been investigated in recent studies in Lateral Epicondylitis. Some studies have been conducted about mills manipulation and Muscle Energy Technique but according to the literature review there is no study exist to determine the effects of Mill's Manipulation along with Muscle Energy Technique in Lateral epicondylitis. Because of this reason, further research required to find out the effects of Mill's Manipulation along with Muscle Energy Technique in pain, Range of motion and disability in lateral epicondylitis. So the aim of the study is to determine whether these techniques are effective and should be incorporated frequently in a clinical setting in relation to the conventional therapy. This study will help the clinician for the identification of the better and quick treatment regime which will have no adverse effects and risks and making them more effective, efficient for the patient with lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Mill's Manipulation, Mill's Manipulation and Muscle Energy Technique
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mill's ManipulationOther
Mill's Manipulation: The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks.
Conventional Therapy:
Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5 min.
Stretching of Wrist Extensors: 15 sec hold, 10 stretches/session/day. Wrist extensors Isometric: resistance 5 to 10 seconds, 15 contractions/ session/day.
Patients will be treated 3 times a week for 2 consecutive weeks.
Mill's Manipulation and Muscle Energy TechniqueOther
Mill's Manipulation:The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks.
Muscle Energy Technique: Extensor carpi radialis stretch for 30 sec repeated 5 times during a single treatment session. Patients will be treated 3 times a week for 2 consecutive weeks.
Conventional Therapy:
Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5min.
Stretching of Wrist Extensors, 15 sec hold, 10 stretches/session/day. Wrist Extensors Isometric, resistance 5 to 10 seconds, 15 contractions/ session/day.
Patients will be treated 3 times a week for 2 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mill's Manipulation and Muscle Energy Technique | Experimental | Group A will receive (Mills Manipulation + Muscle Energy Technique + Conventional therapy). Receives: Other: Mill's Manipulation and Muscle Energy Technique |
| Mill's Manipulation | Other | Group B will receive (Mills Manipulation + Conventional therapy). Receives: Other: Mill's Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The numeric pain rating scale (NPRS) measure the subjective intensity of pain. NPRS is an eleven point scale from 0 to 10 is the most commonly used version which has good test-retest reliability ( r= .79-.96). The NPRS is a reliable and valid pain assessment scale in LE.
Measured: 2 weeks
Goniometer
Universal goniometer is use to measure wrist ROM in flexion , extension, radial deviation, ulnar deviation, forearm pronation and forearm supination.The intraclass correlation coefficients (ICC) ranged from 0.945 to 0.973 which are classified for the goniometer measurements.
Measured: 2 weeks
PRFEQ
The PRTEE, formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) PAIN subscale: (0 = no pain, 10 = worst imaginable) Pain - 5 items 2) FUNCTION subscale: (0 = no difficulty, 10 = unable to do) Specific activities - 6 items , Usual activities - 4 items . Test-retest reliability of Korea version PRTEE was good total ICC= .962 (CI=.922-,982). Therefore, it is a useful measure to evaluate the conditions of patients with lateral epicondylitis.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start31 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamaila Yaqub, Masters, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500585
- Sponsor's protocol ID
- REC/RCR & AHS/01788
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahoo S, Mohanty RK, Mohapatra J, Equebal A, Das SP. Efficacy of extension wrist hand orthosis on pain, grip strength and electromyographic activities in lateral epicondylitis: A randomized single-blind clinical trial. J Hand Ther. 2023 Oct-Dec;36(4):796-804. doi: 10.1016/j.jht.2023.06.006. Epub 2023 Jul 18.
PubMed 37474430Kinandana GP, Dewi AANTN, Winaya IMN, Antari NKAJ, Wibawa A, Adhitya IPGS. The Efficacy of Blood Flow Restriction Training for Grip Strength and Disability in Lateral Epicondylitis. Bali Medical Journal. 2023;12(1):410-5.
Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.
PubMed 23796685Bagcaci S, Unuvar BS, Gercek H, Ugurlu I, Sert OA, Yilmaz K. A randomized controlled trial on pain, grip strength, and functionality in lateral elbow pain: Mulligan vs muscle energy techniques. J Back Musculoskelet Rehabil. 2023;36(2):419-427. doi: 10.3233/BMR-220061.
PubMed 36120766Nambi G, Alghadier M, Verma A, Aldhafian OR, Alshahrani NN, Saleh AK, Omar MA, Hassan TGT, Ibrahim MNA, El Behairy HF. Clinical and radiological effects of Corticosteroid injection combined with deep transverse friction massage and Mill's manipulation in lateral epicondylalgia-A prospective, randomized, single-blinded, sham controlled trial. PLoS One. 2023 Feb 13;18(2):e0281206. doi: 10.1371/journal.pone.0281206. eCollection 2023.
PubMed 36780557Shukla N, Sharma D, Kumar C, Dixit N. A Comparative Analysis of Effectiveness of Mulligan's Mobilisation Versus Cyriax Approach in the Case of Tennis Elbow. Rivista Italiana di Filosofia Analitica Junior. 2023;14(1):333-41.
Cheatham SW, Stull KR, Kolber MJ. Roller massage: is the numeric pain rating scale a reliable measurement and can it direct individuals with no experience to a specific roller density? J Can Chiropr Assoc. 2018 Dec;62(3):161-169.
PubMed 30662071Khuman PR, Trivedi P, Devi S, Sathyavani D, Nambi G, Shah K. Myofascial release technique in chronic lateral epicondylitis: a randomized controlled study. Int J Health Sci Res. 2013;3(7):45-52.
Surangsrirat D, Bualuangngam T, Sri-iesaranusorn P, Chaiyaroj A, Buekban C, Thanawattano C, et al. Comparison of the Wrist Range of Motion Measurement between Inertial Measurement Unit Glove, Smartphone Device and Standard Goniometer. Applied Sciences. 2022;12(7):3418.
Armstrong AD, MacDermid JC, Chinchalkar S, Stevens RS, King GJ. Reliability of range-of-motion measurement in the elbow and forearm. J Shoulder Elbow Surg. 1998 Nov-Dec;7(6):573-80. doi: 10.1016/s1058-2746(98)90003-9.
PubMed 9883416Chapleau J, Canet F, Petit Y, Laflamme GY, Rouleau DM. Validity of goniometric elbow measurements: comparative study with a radiographic method. Clin Orthop Relat Res. 2011 Nov;469(11):3134-40. doi: 10.1007/s11999-011-1986-8. Epub 2011 Jul 21.
PubMed 21779866Lee D-R, Kim J-S. Reliability and validity of the Korean version of patient-rated tennis elbow evaluation. Journal of Korean Society of Physical Medicine. 2014;9(1):25-33.
Kalaskar G, Gurjalwar I, Phansopkar P, Chitale N, Wadhokar OC, Arora SP. Effect of Cyriax physiotherapy and conventional ultrasound on lateral epicondylitis.
Saraswati PAS, Thanaya SAP, Nugraha MHS. The Effectiveness Of Dry Needling Versus Muscle Energy Technique Combined With Ultrasound Therapy In Reducing Disability Due To Tennis Elbow. Jurnal Keterapian Fisik. 2022:80-7.
Parmar BA, Shukla YU. Effect of eccentric versus concentric exercise on pain, grip strength and function in lateral epicondylitis-a comparative study. Int J Sci Healthcare Res. 2020;5(2):98-109.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mill's Manipulation Along With Muscle Energy Technique in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06500585
- Acronym / sponsor ID
- REC/RCR & AHS/01788
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Jul 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.
The effects of Muscle Energy Technique intervention have been investigated in recent studies in Lateral Epicondylitis. Some studies have been conducted about mills manipulation and Muscle Energy Technique but according to the literature review there is no study exist to determine the effects of Mill's Manipulation along with Muscle Energy Technique in Lateral epicondylitis. Because of this reason, further research required to find out the effects of Mill's Manipulation along with Muscle Energy Technique in pain, Range of motion and disability in lateral epicondylitis. So the aim of the study is to determine whether these techniques are effective and should be incorporated frequently in a clinical setting in relation to the conventional therapy. This study will help the clinician for the identification of the better and quick treatment regime which will have no adverse effects and risks and making them more effective, efficient for the patient with lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mill's Manipulation and Muscle Energy Technique | Experimental | Other: Mill's Manipulation and Muscle Energy TechniqueGroup A will receive (Mills Manipulation + Muscle Energy Technique + Conventional therapy). |
| Mill's Manipulation | Other | Other: Mill's ManipulationGroup B will receive (Mills Manipulation + Conventional therapy). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient that have been diagnosed with lateral epicondylitis (pain and point tenderness over lateral epicondyle and / or 1-2cm distal to epicondyle).
- Both male and female patients between the age group of 18 to 45 years old.
- Any of the following tests positive: Cozen Test, Mills, Maudsley.
Key exclusion criteria (10 listed)
- History of rheumatic arthritis
- History of elbow instability
- History of former fracture of the elbow
- History of cervical radiculopathy.
- History of radial tunnel syndrome (Patient with RTS will report pain over lateral forearm approximately 3 to 5 cm distal to the elbow worsens with rotational movements of the forearm).
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 |
|---|---|---|
| Mill's ManipulationMill's Manipulation: The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks. Conventional Therapy: Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5 min. Stretching of Wrist Extensors: 15 sec hold, 10 stretches/session/day. Wrist extensors Isometric: resistance 5 to 10 seconds, 15 contractions/ session/day. Patients will be treated 3 times a week for 2 consecutive weeks. | Other | Mill's Manipulation |
| Mill's Manipulation and Muscle Energy TechniqueMill's Manipulation:The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks. Muscle Energy Technique: Extensor carpi radialis stretch for 30 sec repeated 5 times during a single treatment session. Patients will be treated 3 times a week for 2 consecutive weeks. Conventional Therapy: Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5min. Stretching of Wrist Extensors, 15 sec hold, 10 stretches/session/day. Wrist Extensors Isometric, resistance 5 to 10 seconds, 15 contractions/ session/day. Patients will be treated 3 times a week for 2 consecutive weeks. | Other | Mill's Manipulation and Muscle Energy Technique |
Primary outcome
NPRS
Time frame: 2 weeks
The numeric pain rating scale (NPRS) measure the subjective intensity of pain. NPRS is an eleven point scale from 0 to 10 is the most commonly used version which has good test-retest reliability ( r= .79-.96). The NPRS is a reliable and valid pain assessment scale in LE.
Goniometer
Time frame: 2 weeks
Universal goniometer is use to measure wrist ROM in flexion , extension, radial deviation, ulnar deviation, forearm pronation and forearm supination.The intraclass correlation coefficients (ICC) ranged from 0.945 to 0.973 which are classified for the goniometer measurements.
PRFEQ
Time frame: 2 weeks
The PRTEE, formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) PAIN subscale: (0 = no pain, 10 = worst imaginable) Pain - 5 items 2) FUNCTION subscale: (0 = no difficulty, 10 = unable to do) Specific activities - 6 items , Usual activities - 4 items . Test-retest reliability of Korea version PRTEE was good total ICC= .962 (CI=.922-,982). Therefore, it is a useful measure to evaluate the conditions of patients with lateral epicondylitis.
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 15 Jul 2024.
- Background: PubMed 37474430Sahoo S, Mohanty RK, Mohapatra J, Equebal A, Das SP. Efficacy of extension wrist hand orthosis on pain, grip strength and electromyographic activities in lateral epicondylitis: A randomized single-blind clinical trial. J Hand Ther. 2023 Oct-Dec;36(4):796-804. doi: 10.1016/j.jht.2023.06.006. Epub 2023 Jul 18.
- BackgroundKinandana GP, Dewi AANTN, Winaya IMN, Antari NKAJ, Wibawa A, Adhitya IPGS. The Efficacy of Blood Flow Restriction Training for Grip Strength and Disability in Lateral Epicondylitis. Bali Medical Journal. 2023;12(1):410-5.
- Background: PubMed 23796685Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.
- Background: PubMed 36120766Bagcaci S, Unuvar BS, Gercek H, Ugurlu I, Sert OA, Yilmaz K. A randomized controlled trial on pain, grip strength, and functionality in lateral elbow pain: Mulligan vs muscle energy techniques. J Back Musculoskelet Rehabil. 2023;36(2):419-427. doi: 10.3233/BMR-220061.
- Background: PubMed 36780557Nambi G, Alghadier M, Verma A, Aldhafian OR, Alshahrani NN, Saleh AK, Omar MA, Hassan TGT, Ibrahim MNA, El Behairy HF. Clinical and radiological effects of Corticosteroid injection combined with deep transverse friction massage and Mill's manipulation in lateral epicondylalgia-A prospective, randomized, single-blinded, sham controlled trial. PLoS One. 2023 Feb 13;18(2):e0281206. doi: 10.1371/journal.pone.0281206. eCollection 2023.
- BackgroundShukla N, Sharma D, Kumar C, Dixit N. A Comparative Analysis of Effectiveness of Mulligan's Mobilisation Versus Cyriax Approach in the Case of Tennis Elbow. Rivista Italiana di Filosofia Analitica Junior. 2023;14(1):333-41.
- Background: PubMed 30662071Cheatham SW, Stull KR, Kolber MJ. Roller massage: is the numeric pain rating scale a reliable measurement and can it direct individuals with no experience to a specific roller density? J Can Chiropr Assoc. 2018 Dec;62(3):161-169.
- BackgroundKhuman PR, Trivedi P, Devi S, Sathyavani D, Nambi G, Shah K. Myofascial release technique in chronic lateral epicondylitis: a randomized controlled study. Int J Health Sci Res. 2013;3(7):45-52.
- BackgroundSurangsrirat D, Bualuangngam T, Sri-iesaranusorn P, Chaiyaroj A, Buekban C, Thanawattano C, et al. Comparison of the Wrist Range of Motion Measurement between Inertial Measurement Unit Glove, Smartphone Device and Standard Goniometer. Applied Sciences. 2022;12(7):3418.
- Background: PubMed 9883416Armstrong AD, MacDermid JC, Chinchalkar S, Stevens RS, King GJ. Reliability of range-of-motion measurement in the elbow and forearm. J Shoulder Elbow Surg. 1998 Nov-Dec;7(6):573-80. doi: 10.1016/s1058-2746(98)90003-9.
- Background: PubMed 21779866Chapleau J, Canet F, Petit Y, Laflamme GY, Rouleau DM. Validity of goniometric elbow measurements: comparative study with a radiographic method. Clin Orthop Relat Res. 2011 Nov;469(11):3134-40. doi: 10.1007/s11999-011-1986-8. Epub 2011 Jul 21.
- BackgroundLee D-R, Kim J-S. Reliability and validity of the Korean version of patient-rated tennis elbow evaluation. Journal of Korean Society of Physical Medicine. 2014;9(1):25-33.
- 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.
Shamaila Yaqub, Masters 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 Mill's Manipulation and Mill's Manipulation and Muscle Energy Technique 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 3 inclusion and 10 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 15 Jul 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?
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?
NPRS (time frame: 2 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?
On the ClinicalTrials.gov record for NCT06500585, which also lists 15 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 15 Jul 2024.