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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05405023
Other study ID # REC/RCR&AHS/22/0128
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 27, 2022
Est. completion date January 27, 2023

Study information

Verified date May 2022
Source Riphah International University
Contact Imran Amjad, Phd
Phone +923324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The distal end of the radius is defined as the area three centimeters proximal to the radio carpal joint, where the radius interfaces with the lunate and scaphoid bone of the wrist. A fracture of the distal radius is usually caused by falling on the outstretched arm. The majority of distal radial fractures are closed injuries in which the overlying skin remains intact. Pain, swelling, bruising, deformity and deformity in the forearm or wrist are common. In women, the incidence of distal radial fracture increases with age from 40 years. The objective of this study will be to determine the Effects of Concentric exercises with and without mulligan wrist mobilization on pain, grip strength, Range of motion and function after distal radius fracture. This study will be a randomized controlled trial and will be conducted in District Head Quarter hospital sheikhupura. The study will be completed in time duration of six months after the approval of synopsis and convenience sampling technique will be used. 18 subjects will be divided in two groups. Group A will follow concentric exercises at wrist including flexion, extension, abduction, adduction, pronation, supination and wrist mobilizations with movements while group B will follow only wrist concentric exercises treatment. MWM based on Mulligan's Recommendation that the patient should not experience any pain. The Location and direction of the glide could be modified so that the MWM was pain free, as advocated in the Mulligan concept. This study will be of 4 weeks, 3 sessions per week. Data will be collected by all participants before 1st session after 6th session and at the end of 12th session by using NPRS, Hand Dynamometer, Goniometer and Patient Rated Wrist Evaluation score. Data will be analyzed by SPSS-25.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date January 27, 2023
Est. primary completion date November 27, 2022
Accepts healthy volunteers No
Gender All
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria: - Age: 35-70 years - Subjects with at least 6 weeks of distal radius fracture - Orthopedic surgeon advise Exclusion Criteria: - Neurological problem affecting upper limb - Parkinson disease - Subjects having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease - Any contraindication to physiotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Concentric exercises with wrist mobilization
Participants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements.
Concentric exercises without wrist mobilization
Participants will receive concentric exercises only.

Locations

Country Name City State
Pakistan DHQ Hospital Sheikhupura Sheikhupura Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Aguilera-Godoy A, Antúnez-Riveros MA, Carrasco-Penna G, Núñez-Cortés R. A post-surgical rehabilitation program for women over 60 years old who underwent surgery in trauma and orthopedic hospital after distal radius fracture. J Bodyw Mov Ther. 2021 Oct;28:362-368. doi: 10.1016/j.jbmt.2021.07.042. Epub 2021 Aug 10. — View Citation

Coughlin T, Norrish AR, Scammell BE, Matthews PA, Nightingale J, Ollivere BJ. Infographic: Comparison of rehabilitation interventions in nonoperatively treated distal radius fractures: a randomized controlled trial of effectiveness. Bone Joint J. 2021 Jun;103-B(6):1031-1032. doi: 10.1302/0301-620X.103B6.BJJ-2021-0729. Review. — View Citation

Gutiérrez-Espinoza H, Araya-Quintanilla F, Olguín-Huerta C, Gutiérrez-Monclus R, Jorquera-Aguilera R, Mathoulin C. Effectiveness of early versus delayed motion in patients with distal radius fracture treated with volar locking plate: A systematic review and meta-analysis. Hand Surg Rehabil. 2021 Feb;40(1):6-16. doi: 10.1016/j.hansur.2020.10.007. Epub 2020 Nov 2. — View Citation

Gutiérrez-Espinoza H, Araya-Quintanilla F, Olguín-Huerta C, Valenzuela-Fuenzalida J, Gutiérrez-Monclus R, Moncada-Ramírez V. Effectiveness of manual therapy in patients with distal radius fracture: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):33-45. doi: 10.1080/10669817.2021.1992090. Epub 2021 Oct 20. — View Citation

Gutiérrez-Espinoza H, Rubio-Oyarzún D, Olguín-Huerta C, Gutiérrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul - Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22. — View Citation

Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101. — View Citation

Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19. Review. — View Citation

Reid SA, Andersen JM, Vicenzino B. Adding mobilisation with movement to exercise and advice hastens the improvement in range, pain and function after non-operative cast immobilisation for distal radius fracture: a multicentre, randomised trial. J Physiother. 2020 Apr;66(2):105-112. doi: 10.1016/j.jphys.2020.03.010. Epub 2020 Apr 11. — View Citation

Shafiee E, MacDermid J, Farzad M, Karbalaei M. A systematic review and meta-analysis of Patient-Rated Wrist (and Hand) Evaluation (PRWE/PRWHE) measurement properties, translation, and/ or cross-cultural adaptation. Disabil Rehabil. 2021 Sep 10:1-15. doi: 10.1080/09638288.2021.1970250. [Epub ahead of print] — View Citation

Stathopoulos N, Dimitriadis Z, Koumantakis GA. Erratum to "Effectiveness of Mulligan's mobilization with movement techniques on pain and disability of peripheral joints: a systematic review with meta-analysis between 2008-2017" [Physiotherapy 105 (March (1)) (2019) 1-9]. Physiotherapy. 2020 Mar;106:219. doi: 10.1016/j.physio.2019.04.002. Epub 2019 Aug 30. — View Citation

Tomruk M, Gelecek N, Basçi O, Özkan MH. Effects of early manual therapy on functional outcomes after volar plating of distal radius fractures: A randomized controlled trial. Hand Surg Rehabil. 2020 May;39(3):178-185. doi: 10.1016/j.hansur.2019.12.002. Epub 2020 Feb 15. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Wrist Pain NPRS is anchored by terms describing pain severity extremes. 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 weeks
Primary Grip Strength Handheld dynamometers are used for measuring grip strength. They are available in manual and digital version so there is a need to know the reliability of manual hand-held dynamometer and digital hand-held for measuring grip strength. Excellent reliability is found for manual and digital handheld dynamometers 4 weeks
Primary Range of motion Goniometer is used to measure Range of motion. Hand-held pencil (HHP) and the plumb line goniometer (PLG) methods are used for measuring active forearm pronation and supination motions in individuals with and without injuries. The HHP and PLG are highly reliable methods for measuring functional forearm pronation and supination. Because plumb line goniometers are not commercially available and the instrumentation for the HHP method is readily accessible, clinicians should consider the latter as their method of choice for measuring functional forearm pronation and supination 4 weeks
Primary Wrist Function For evaluating function Patient Rated Wrist Evaluation (PRWE) score is used. High-quality evidence supports the use of PRWE/PRWHE as a reliable, valid, and structurally sound questionnaire to assess pain and disability in patients with various wrist and hand injuries. The PRWE/PRWHE has been translated into 21 languages. High-quality evidence supports very good structural and cross-cultural validity, internal consistency, test-retest reliability, measurement error, and hypothesis testing for construct validity against DASH in wrist and hand injuries. However, low-quality evidence supports acceptable responsiveness property 4 weeks
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