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Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Baseline Treatment along with Mill's manipulation
Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral Epicondylitis, Elbow, Pain, Tennis Elbow, Mills Manipulation, Mulligan, Pain Release Phenomena, Hand Grip Strength, Elbow Function, NPRS, PRTEE, Hand Held Dynamometer

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Ittefaq Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Baseline treatment along with Mill's manipulation

Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena

Outcomes

Primary Outcome Measures

Numeric Pain Rate Scale
The NPRS for pain is a unidirectional measure of pain intensity in adults similar to the pain 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
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
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).

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06087081
Brief Title
Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Lateral Epicondylitis, Elbow, Pain, Tennis Elbow, Mills Manipulation, Mulligan, Pain Release Phenomena, Hand Grip Strength, Elbow Function, NPRS, PRTEE, Hand Held Dynamometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Baseline treatment along with Mill's manipulation
Arm Title
Group B
Arm Type
Experimental
Arm Description
Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena
Intervention Type
Other
Intervention Name(s)
Baseline Treatment along with Mill's manipulation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Baseline Treatment along with Mill's manipulation and Mulligan's pain relief phenomena
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rate Scale
Description
The NPRS for pain is a unidirectional measure of pain intensity in adults similar to the pain 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).
Time Frame
4th Week
Title
Hand Held Dynamometer
Description
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)
Time Frame
4th Week
Title
Patient-Rated Tennis Elbow Evaluation
Description
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).
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Humera Mubashar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ittefaq Hospital Trust
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humera Mubashar, MS
Phone
03084157979
Email
Humera.mubashar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aitmad Ur Rahman, MS-OMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11155299
Citation
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.
Results Reference
background
PubMed Identifier
8316782
Citation
Armstrong 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.
Results Reference
background
PubMed Identifier
23997125
Citation
Ahmad 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.
Results Reference
background
PubMed Identifier
34674287
Citation
Bretschneider 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.
Results Reference
background
PubMed Identifier
35323612
Citation
Aldajah 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.
Results Reference
background
PubMed Identifier
35252465
Citation
Fahmy 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.
Results Reference
background
Citation
8. 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.
Results Reference
background
Citation
1. Runge F. Zur genese und behandlung des schreibekrampfes. Berl Klin Wochenschr. 1873;10(1):245-8.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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-.
Results Reference
background
Citation
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).
Results Reference
background
Citation
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.
Results Reference
background

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Mills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral Epicondylitis

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