NCT05405023

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 31, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

DisabilityRange of MovementConcentric exercisesMovementFracture

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Concentric exercises with wrist mobilization

EXPERIMENTAL

concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements

Other: Concentric exercises with wrist mobilization

Concentric exercises without wrist mobilization

ACTIVE COMPARATOR

concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation

Other: Concentric exercises without wrist mobilization

Interventions

Participants will receive concentric exercise including wrist flexion, extension, and abduction, adduction, supination and pronation plus wrist mobilizations with movements.

Concentric exercises with wrist mobilization

Participants will receive concentric exercises only.

Concentric exercises without wrist mobilization

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 35-70 years
  • Subjects with at least 6 weeks of distal radius fracture
  • Orthopedic surgeon advise

You may not qualify if:

  • Neurological problem affecting upper limb
  • Parkinson disease
  • Subjects having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease
  • Any contraindication to physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital Sheikhupura

Sheikhupura, Punjab Province, 39350, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 25657938BACKGROUND
  • 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.

    PMID: 32193679BACKGROUND
  • Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-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.

    PMID: 28342739BACKGROUND
  • Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Valenzuela-Fuenzalida J, Gutierrez-Monclus R, Moncada-Ramirez 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.

    PMID: 34668847BACKGROUND
  • 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. No abstract available.

    PMID: 34058884BACKGROUND
  • Gutierrez-Espinoza H, Araya-Quintanilla F, Olguin-Huerta C, Gutierrez-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.

    PMID: 33144249BACKGROUND
  • Tomruk M, Gelecek N, Basci O, Ozkan 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.

    PMID: 32070793BACKGROUND
  • 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.

    PMID: 32291223BACKGROUND
  • Aguilera-Godoy A, Antunez-Riveros MA, Carrasco-Penna G, Nunez-Cortes 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.

    PMID: 34776165BACKGROUND
  • 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. No abstract available.

    PMID: 31477334BACKGROUND
  • 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. 2022 Nov;44(22):6551-6565. doi: 10.1080/09638288.2021.1970250. Epub 2021 Sep 10.

    PMID: 34505793BACKGROUND

MeSH Terms

Conditions

Wrist FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Saba Rafique, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

May 27, 2022

Primary Completion

November 27, 2022

Study Completion

January 27, 2023

Last Updated

June 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations