Lateral EpicondylitisNCT06087081
Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis
A study testing Baseline Treatment along with Mill's manipulation and Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find the comparative effects of mills manipulation with or without Mulligan pain release phenomena on the pain, grip strength, and function in patients with Lateral Epicondylitis. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Baseline Treatment along with Mill's manipulation and Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 20 Jan 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects diagnosed with lateral epicondylitis with positive Cozen test
- NPRS >3
- Both male and female patients
- Sub-acute lateral epicondylitis >4weeks-<3 months
- Subjects with age range 20-40 year
Who cannot join
- Acute lateral epicondylitis
- Subjects with elbow and around elbow fracture
- Subjects with ligament injury around elbow joint
- Any neurological conditions
- Any open wounds around the area of elbow
- Hyper-sensitive skin, skin allergies, diagnosed subjects with malignancy, diagnosed subjects skin diseases, diagnosed subjects with systemic illness
- Traumatic injury to the elbow joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mills Manipulation With and Without Mulligan Pain Release Phenomena on Pain, Hand Grip Strength and Function in Patients With Lateral Epicondylitis
The aim of this study is to find the comparative effects of mills manipulation with or without Mulligan pain release phenomena on the pain, grip strength, and function in patients with Lateral Epicondylitis. The results of this study will provide clinicians with valuable insights into the most effective treatment approach for lateral epicondylitis, enabling them to stay up-to-date with the latest practice methods and optimize patient care.
- Conditions
- Lateral Epicondylitis
- Being tested
- Baseline Treatment along with Mill's manipulation, Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena
- Keywords
- Lateral Epicondylitis, Elbow, Pain, Tennis Elbow, Mills Manipulation, Mulligan, Pain Release Phenomena, Hand Grip Strength, Elbow Function, NPRS, PRTEE, Hand Held Dynamometer
- 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.
Baseline Treatment along with Mill's manipulationOther
Position the patient on a chair with a backrest and stand behind the patient. Support the patient's arm under the crook of the elbow with the shoulder joint abducted to 90° and medially rotated. The forearm will automatically fall into pronation. Place the thumb of your other hand in the web space between the patient's thumb and index finger and fully flex the patient's wrist and pronate the forearm. Move the hand supporting the crook of the elbow on to the posterior surface of the elbow joint and, while maintaining full Wrist flexion and pronation, extend the patient's elbow until you feel that all the slack Has been taken up in the tendon. Step sideways to stand behind the patient's head, Taking Care to prevent the patient from leaning away either forwards or sideways, which would reduce the tension on the tendon.
Each exercise will be done 10 times for 5 sets each with a rest interval of 10 seconds in between each set for a period of 4 weeks
Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomenaOther
In addition to Group A mentioned protocols Pain release phenomenon (PRP) was delivered as well. The Pain Release Phenomenon Technique (PRPS) is a technique pioneered by Brian Mulligan for management of Pain. There are different types of Pain release Phenomenon as follows:
- Stretch PRP: affected muscle is eccentrically contracted.
- Contraction PRP: affected muscle is concentrically contracted.
- Compression PRP: affected joint surfaces are compressed together.
- Distraction PRP: affected joint surfaces are distracted away from each other. The types of PRP are performed along with pertained duration of hold time by the therapist. And always painful PRP technique is chosen for the treatment. In the present study stretch PRP technique was used which provoked pain stimuli and was maintained for 15-20 seconds. Each exercise will be done 10 times for 5 sets each with a rest interval of 10 seconds in between each set for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Baseline treatment along with Mill's manipulation Receives: Other: Baseline Treatment along with Mill's manipulation |
| Group B | Experimental | Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena Receives: Other: Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rate Scale
The NPRS for pain is a unidirectional measure of pain intensity in adults similar to the pain Visual Analogue Scale(VAS), the NPRS is anchored by terms describing pain severity extremes. The common format is a horizontal bar or line with 11-items (0-10). 0 on NPRS indicates no pain, 5 indicates moderate pain and 10 indicates worst possible pain. NPRS is easy to administer and takes less than 1minute. The NPRS can be administered verbally (on telephone) or graphically for self- completion. Reliability: high test-retest reliability (r=0.96). Validity: (0.86-0.95).
Measured: 4th Week
Hand Held Dynamometer
The maximal grip strength of the affected arm was assessed using a grip-strength dynamometer. Patients were asked to grip the dynamometer as hard as possible 3 times at 10 s rest interval. Grip force should be applied smoothly without rapid jerking motion. Patient must be seated with 90 degrees of elbow flexion, shoulder adduction, slight extension in the wrist, and the forearm in the neutral position. The highest grip-strength number was registered. Reliability: high test-retest reliability(r=0.9864)
Measured: 4th Week
Patient-Rated Tennis Elbow Evaluation
Functional Disability was measured by PRTEE, a 15-item questionnaire designed to measure forearm pain and disability in patients with Lateral Epicondylitis. Patients have to rate their levels of tennis elbow pain and disability from 0 to 10 and consists of 2 sub-scales. There is a pain sub-scale with 5 items (0 = no pain, 50 = worst pain) and Functional sub-scale consists of Specific activities with 6 items (0 = no hinder, 60 =unable to do) and Usual activities with 4 items (0 = no difficulty, 10 = unable to do). The PRTEE was found to be a reliable, reproducible and sensitive instrument for the assessment of pain and disability in chronic lateral epicondylitis subjects (Cronbach's alpha is 0.98).
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 posted17 Oct 2023
- Study start20 Oct 2023
- Primary completion30 Dec 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087081
- Sponsor's protocol ID
- REC/RCR&AHS/23/0144
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker CL Jr, Murphy KP, Gottlob CA, Curd DT. Arthroscopic classification and treatment of lateral epicondylitis: two-year clinical results. J Shoulder Elbow Surg. 2000 Nov-Dec;9(6):475-82. doi: 10.1067/mse.2000.108533.
PubMed 11155299Armstrong TJ, Buckle P, Fine LJ, Hagberg M, Jonsson B, Kilbom A, Kuorinka IA, Silverstein BA, Sjogaard G, Viikari-Juntura ER. A conceptual model for work-related neck and upper-limb musculoskeletal disorders. Scand J Work Environ Health. 1993 Apr;19(2):73-84. doi: 10.5271/sjweh.1494.
PubMed 8316782Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
PubMed 23997125Bretschneider SF, Los FS, Eygendaal D, Kuijer PPFM, van der Molen HF. Work-relatedness of lateral epicondylitis: Systematic review including meta-analysis and GRADE work-relatedness of lateral epicondylitis. Am J Ind Med. 2022 Jan;65(1):41-50. doi: 10.1002/ajim.23303. Epub 2021 Oct 21.
PubMed 34674287Aldajah S, Alashram AR, Annino G, Romagnoli C, Padua E. Analgesic Effect of Extracorporeal Shock-Wave Therapy in Individuals with Lateral Epicondylitis: A Randomized Controlled Trial. J Funct Morphol Kinesiol. 2022 Mar 18;7(1):29. doi: 10.3390/jfmk7010029.
PubMed 35323612Fahmy FS, ElAttar M, Salem HF. Hand-Grip Strength and Return to Heavy Manual Work at a Mean 5-Year Follow-up After Arthroscopic Release of Recalcitrant Lateral Epicondylitis. Orthop J Sports Med. 2022 Feb 24;10(2):23259671221078586. doi: 10.1177/23259671221078586. eCollection 2022 Feb.
PubMed 352524658. Chintamani R. Effect of Mulligan's Pain Release Phenomenon on Ted in Subjects with Subacute Lateral Epicondylitis. Journal of Complementary and Alternative Medical Research. 2021;16(4):59-70.
1. Runge F. Zur genese und behandlung des schreibekrampfes. Berl Klin Wochenschr. 1873;10(1):245-8.
9. Sahu RK. A Comparative Study of Effectiveness of Mulligan's Mobilisation with Movement and Cyriax Deep Transverse Friction along with Mill's Manipulation in Individuals with Chronic Lateral Epicondylitis. 2020.
10. Memon AG, Latif FA, Sanaullah M, Hussain MI, Irum S, Rehman FU. Prevalence of lateral epicondylitis among restaurant chefs with low level of serum Vitamin D. Rawal Medical Journal. 2023;48(2):422-.
11. Zami MDZ, Pristianto A, Nasrullah N. The Effectiveness of Mulligan Mobilization With Movement (MWM) in Lateral Epicondylitis: a Critical Review. FISIO MU: Physiotherapy Evidences. 2023;4(1).
12. Rahman H, Chaturvedi PA, Apparao P, Srithulasi PR. Effectiveness of mulligan mobilisation with movement compared to supervised exercise program in subjects with lateral epicondylitis. Int J Physiotherapy Res. 2016;4(2):1394-400.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mills Manipulation With and Without Mulligan Pain Release Phenomena on Pain, Hand Grip Strength and Function in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06087081
- Acronym / sponsor ID
- REC/RCR&AHS/23/0144
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Elbow, Pain, Tennis Elbow, Mills Manipulation, Mulligan, Pain Release Phenomena, Hand Grip Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 17 Oct 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.
The aim of this study is to find the comparative effects of mills manipulation with or without Mulligan pain release phenomena on the pain, grip strength, and function in patients with Lateral Epicondylitis. The results of this study will provide clinicians with valuable insights into the most effective treatment approach for lateral epicondylitis, enabling them to stay up-to-date with the latest practice methods and optimize patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Baseline Treatment along with Mill's manipulationBaseline treatment along with Mill's manipulation |
| Group B | Experimental | Other: Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomenaBaseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects diagnosed with lateral epicondylitis with positive Cozen test
- NPRS >3
- Both male and female patients
- Sub-acute lateral epicondylitis >4weeks-<3 months
- Subjects with age range 20-40 year
Key exclusion criteria (7 listed)
- Acute lateral epicondylitis
- Subjects with elbow and around elbow fracture
- Subjects with ligament injury around elbow joint
- Any neurological conditions
- Any open wounds around the area of elbow
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 |
|---|---|---|
| Baseline Treatment along with Mill's manipulationPosition the patient on a chair with a backrest and stand behind the patient. Support the patient's arm under the crook of the elbow with the shoulder joint abducted to 90° and medially rotated. The forearm will automatically fall into pronation. Place the thumb of your other hand in the web space between the patient's thumb and index finger and fully flex the patient's wrist and pronate the forearm. Move the hand supporting the crook of the elbow on to the posterior surface of the elbow joint and, while maintaining full Wrist flexion and pronation, extend the patient's elbow until you feel that all the slack Has been taken up in the tendon. Step sideways to stand behind the patient's head, Taking Care to prevent the patient from leaning away either forwards or sideways, which would reduce the tension on the tendon. Each exercise will be done 10 times for 5 sets each with a rest interval of 10 seconds in between each set for a period of 4 weeks | Other | Group A |
| Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomenaIn addition to Group A mentioned protocols Pain release phenomenon (PRP) was delivered as well. The Pain Release Phenomenon Technique (PRPS) is a technique pioneered by Brian Mulligan for management of Pain. There are different types of Pain release Phenomenon as follows: 1. Stretch PRP: affected muscle is eccentrically contracted. 2. Contraction PRP: affected muscle is concentrically contracted. 3. Compression PRP: affected joint surfaces are compressed together. 4. Distraction PRP: affected joint surfaces are distracted away from each other. The types of PRP are performed along with pertained duration of hold time by the therapist. And always painful PRP technique is chosen for the treatment. In the present study stretch PRP technique was used which provoked pain stimuli and was maintained for 15-20 seconds. Each exercise will be done 10 times for 5 sets each with a rest interval of 10 seconds in between each set for a period of 4 weeks | Other | Group B |
Primary outcome
Numeric Pain Rate Scale
Time frame: 4th Week
The NPRS for pain is a unidirectional measure of pain intensity in adults similar to the pain Visual Analogue Scale(VAS), the NPRS is anchored by terms describing pain severity extremes. The common format is a horizontal bar or line with 11-items (0-10). 0 on NPRS indicates no pain, 5 indicates moderate pain and 10 indicates worst possible pain. NPRS is easy to administer and takes less than 1minute. The NPRS can be administered verbally (on telephone) or graphically for self- completion. Reliability: high test-retest reliability (r=0.96). Validity: (0.86-0.95).
Hand Held Dynamometer
Time frame: 4th Week
The maximal grip strength of the affected arm was assessed using a grip-strength dynamometer. Patients were asked to grip the dynamometer as hard as possible 3 times at 10 s rest interval. Grip force should be applied smoothly without rapid jerking motion. Patient must be seated with 90 degrees of elbow flexion, shoulder adduction, slight extension in the wrist, and the forearm in the neutral position. The highest grip-strength number was registered. Reliability: high test-retest reliability(r=0.9864)
Patient-Rated Tennis Elbow Evaluation
Time frame: 4th Week
Functional Disability was measured by PRTEE, a 15-item questionnaire designed to measure forearm pain and disability in patients with Lateral Epicondylitis. Patients have to rate their levels of tennis elbow pain and disability from 0 to 10 and consists of 2 sub-scales. There is a pain sub-scale with 5 items (0 = no pain, 50 = worst pain) and Functional sub-scale consists of Specific activities with 6 items (0 = no hinder, 60 =unable to do) and Usual activities with 4 items (0 = no difficulty, 10 = unable to do). The PRTEE was found to be a reliable, reproducible and sensitive instrument for the assessment of pain and disability in chronic lateral epicondylitis subjects (Cronbach's alpha is 0.98).
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 13 Mar 2024.
- Background: PubMed 11155299Baker CL Jr, Murphy KP, Gottlob CA, Curd DT. Arthroscopic classification and treatment of lateral epicondylitis: two-year clinical results. J Shoulder Elbow Surg. 2000 Nov-Dec;9(6):475-82. doi: 10.1067/mse.2000.108533.
- Background: PubMed 8316782Armstrong TJ, Buckle P, Fine LJ, Hagberg M, Jonsson B, Kilbom A, Kuorinka IA, Silverstein BA, Sjogaard G, Viikari-Juntura ER. A conceptual model for work-related neck and upper-limb musculoskeletal disorders. Scand J Work Environ Health. 1993 Apr;19(2):73-84. doi: 10.5271/sjweh.1494.
- Background: PubMed 23997125Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
- Background: PubMed 34674287Bretschneider SF, Los FS, Eygendaal D, Kuijer PPFM, van der Molen HF. Work-relatedness of lateral epicondylitis: Systematic review including meta-analysis and GRADE work-relatedness of lateral epicondylitis. Am J Ind Med. 2022 Jan;65(1):41-50. doi: 10.1002/ajim.23303. Epub 2021 Oct 21.
- Background: PubMed 35323612Aldajah S, Alashram AR, Annino G, Romagnoli C, Padua E. Analgesic Effect of Extracorporeal Shock-Wave Therapy in Individuals with Lateral Epicondylitis: A Randomized Controlled Trial. J Funct Morphol Kinesiol. 2022 Mar 18;7(1):29. doi: 10.3390/jfmk7010029.
- Background: PubMed 35252465Fahmy FS, ElAttar M, Salem HF. Hand-Grip Strength and Return to Heavy Manual Work at a Mean 5-Year Follow-up After Arthroscopic Release of Recalcitrant Lateral Epicondylitis. Orthop J Sports Med. 2022 Feb 24;10(2):23259671221078586. doi: 10.1177/23259671221078586. eCollection 2022 Feb.
- Background8. Chintamani R. Effect of Mulligan's Pain Release Phenomenon on Ted in Subjects with Subacute Lateral Epicondylitis. Journal of Complementary and Alternative Medical Research. 2021;16(4):59-70.
- Background1. Runge F. Zur genese und behandlung des schreibekrampfes. Berl Klin Wochenschr. 1873;10(1):245-8.
- Background9. Sahu RK. A Comparative Study of Effectiveness of Mulligan's Mobilisation with Movement and Cyriax Deep Transverse Friction along with Mill's Manipulation in Individuals with Chronic Lateral Epicondylitis. 2020.
- Background10. Memon AG, Latif FA, Sanaullah M, Hussain MI, Irum S, Rehman FU. Prevalence of lateral epicondylitis among restaurant chefs with low level of serum Vitamin D. Rawal Medical Journal. 2023;48(2):422-.
- Background11. Zami MDZ, Pristianto A, Nasrullah N. The Effectiveness of Mulligan Mobilization With Movement (MWM) in Lateral Epicondylitis: a Critical Review. FISIO MU: Physiotherapy Evidences. 2023;4(1).
- Background12. Rahman H, Chaturvedi PA, Apparao P, Srithulasi PR. Effectiveness of mulligan mobilisation with movement compared to supervised exercise program in subjects with lateral epicondylitis. Int J Physiotherapy Res. 2016;4(2):1394-400.
- 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.
Humera Mubashar, 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 Baseline Treatment along with Mill's manipulation and Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena 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 5 inclusion and 7 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 13 Mar 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?
Numeric Pain Rate Scale (time frame: 4th Week). 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 NCT06087081, which also lists 12 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 13 Mar 2024.