Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05039827
Other study ID # REC/RCR & AHS/21/0420
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date July 15, 2021

Study information

Verified date September 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. This is an RCT study. Subjects who fulfilled inclusion criteria will be taken for the study. Before conducting the actual method for subjects, lateral epicondylitis evaluation is done. First day before treatment, pain evaluation were done by using Numeric Pain Rating Scale. Muscle power was assessed by MMT (Manual Muscle Testing) and the function level are tested by Patient-Related Tennis Elbow Evaluation (PRTEE) questionnaire and asked to mark the results. Subjects will be divided into 2 groups randomly by lottery method. Each group consists of 15 patients. Group A will be given MWM; Group B will be given soft tissue mobilization. Both groups will be given with the above said methods for alternative days in a week as per 3 sessions per week for 4 weeks. At the end of program subjects will be reassessed by recording muscle strength, pain intensity and functional level. Finally pre and post recordings will be compared and analyzed statistically.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 15, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 30 Years
Eligibility Inclusion Criteria: - Tennis players. - Age group between 15-30 years. - Positive specific tests.(cozen and mills test) - Subjects having lateral epicondylitis pain for at least 4 weeks, muscle power for wrist muscle should be increase with activity against resistance, average pain level of 3-cm or more on a 10-cm Numerical pain rating scale Exclusion Criteria: - Any neurological disorder. - Other elbow deformity or joint pathology. fracture of upper limb

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobilization with movement
Heating fermentation was done for 10 minutes as baseline treatment. MWM with wrist extension was given for alternative days in a week as per 3 sessions per week for 4 weeks.
Soft Tissue Mobilization
Heating fermentation was done for 10 minutes as baseline treatment. Parallel and longitudinal massage was given for alternative days in a week as per 3 sessions per week for 4 weeks

Locations

Country Name City State
Pakistan Hidayat Gillani Orthopedic Complex Sahiwal Sahiwal Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Ahmed A, Ibrar M, Arsh A, Wali S, Hayat S, Abass S. Comparing the effectiveness of Mulligan mobilization versus Cyriax approach in the management of patients with subacute lateral epicondylitis. J Pak Med Assoc. 2021 Jan;71(1(A)):12-15. doi: 10.47391/JPMA.186. — View Citation

Bisset L, Paungmali A, Vicenzino B, Beller E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005 Jul;39(7):411-22; discussion 411-22. Review. — View Citation

Castillo-Lozano R, Casuso-Holgado MJ. Incidence of musculoskeletal sport injuries in a sample of male and female recreational paddle-tennis players. J Sports Med Phys Fitness. 2017 Jun;57(6):816-821. doi: 10.23736/S0022-4707.16.06240-X. Epub 2016 Feb 12. — View Citation

Coombes BK, Connelly L, Bisset L, Vicenzino B. Economic evaluation favours physiotherapy but not corticosteroid injection as a first-line intervention for chronic lateral epicondylalgia: evidence from a randomised clinical trial. Br J Sports Med. 2016 Nov;50(22):1400-1405. doi: 10.1136/bjsports-2015-094729. Epub 2015 Jun 2. — View Citation

Lucado AM, Dale RB, Vincent J, Day JM. Do joint mobilizations assist in the recovery of lateral elbow tendinopathy? A systematic review and meta-analysis. J Hand Ther. 2019 Apr - Jun;32(2):262-276.e1. doi: 10.1016/j.jht.2018.01.010. Epub 2018 Apr 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") 4 Week
Primary Grip Strength Manual muscle testing as used to test grip strength. It involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly[1]:
Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance
4 week
Primary Functional activity Patient Related Tennis Elbow Evaluation (PRTEE) was used.The PrTEEQ is a 15-item questionnaire, it's designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients have to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales. There is the pain subscale (0 = no pain, 10 = worst imaginable) en the function subscale (0 = no difficulty, 10 = unable to do) 4 weeks
See also
  Status Clinical Trial Phase
Withdrawn NCT02861183 - Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow) N/A
Recruiting NCT02304952 - Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia N/A
Completed NCT02596659 - Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow N/A
Completed NCT00674622 - Prolotherapy for the Treatment of Chronic Lateral Epicondylitis Phase 2/Phase 3
Completed NCT06206109 - The Effect of Tendon Tears on Lateral Epicondylitis
Recruiting NCT04442321 - Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia N/A
Not yet recruiting NCT04382144 - Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis Phase 4
Recruiting NCT03863847 - A Neurofeedback Treatment for Chronic Musculoskeletal Pain N/A
Completed NCT04576195 - Immediate Neurophysiological Effects of PENS on Radial Nerve in Patients With Lateral Epicondylalgia N/A
Recruiting NCT02343809 - Diacutaneous Fibrolysis on Lateral Epicondylitis Phase 3
Completed NCT05084664 - Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow. N/A
Recruiting NCT00395616 - Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow N/A
Completed NCT00130949 - ALGRX 4975 in the Treatment of Tennis Elbow Phase 2
Recruiting NCT06116175 - Lateral Epicondylitis Continuous Radiofrequency Microtenotomy N/A
Recruiting NCT05326763 - Functional and Electromyographical Changes After PRP or Dextrose Injection in Chronic Lateral Epicondylitis Phase 3
Completed NCT04454060 - Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow
Enrolling by invitation NCT04445727 - Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis N/A
Completed NCT04454047 - Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow——Mid-and-short Term Retrospective Study of 50 Cases
Completed NCT04395417 - Injection Therapy in Patients With Lateral Epicondylitis N/A
Not yet recruiting NCT06382805 - Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis N/A