NCT05976724

Brief Summary

Distal radius fractures (DRF) are the most common upper extremity disorders encountered in clinical practice. With an understanding of the mechanics of distal radius fractures, surgical intervention, and bone healing, the therapist can modify the therapy program according to the patient's individual needs. The therapeutic process is begun in the crucial stage of bone healing during fracture immobilization. By addressing edema reduction and early range of motion of the uninvolved joints, most problems can be avoided before cast or fixator removal. Rehabilitation following the immobilization period should focus on regaining wrist movements provided that earlier problems have been addressed properly. During the rehabilitative process, the therapist can incorporate scar management, modalities, joint mobilization, active and passive range of motion, splinting, and strengthening to maximize the patient's functional result. Massage and mobilization techniques are used in the treatment of DRF due to their analgesic effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan) is a manual therapy method applies to correct the limitation of movement in the joint and to relieve pain and functional disorders. Many studies have shown that MWM technique provides faster and momentary painless joint movement compared to other physical therapy modalities. The patient group with DRF has a large place in the general population and long treatment processes cause both labour loss and economic loss. Therefore, this study aimed to examine the effectiveness of MWM technique in cases with distal radius fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

June 26, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

PainRange of motion

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS). As a simple and commonly applied method, VAS is considered to be both valid and reliable in measuring patient pain intensity. The patients in the current study were each asked with indicating the intensity of their pain experienced within the past 24 hours by marking on a 10-cm line scale, where 0 = "No pain" and 10 = "Maximum pain

    0-5 week

Study Arms (2)

Mobilization with movement

EXPERIMENTAL

Mobilization with movement technique and traditional physiotherapy will be applied to the intervention group. Also patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.

Other: TENS, exerciseOther: Mulligan mobilisation

Control group

ACTIVE COMPARATOR

Patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.

Other: TENS, exercise

Interventions

TENS: The patients were sat in a chair positioned next to a treatment table. The hand to be treated was placed on the treatment table with the forearm in the supine position. Electrodes were then placed on the transverse carpal ligament and palmar surface of the hand. Conventional TENS was applied, with the current transition time set to 50-100 µs, and performed at a frequency of 100 Hz for a period of 20 minutes at an amplitude that did not cause muscle contraction or any feeling of numbness or tingling. The supervised exercises were performed by the patients in a seated position. Strengthening exercises were performed with both hands by means of Digi-Flex hand exerciser (IMC Products Corp, Hicksville, New York), modeling mass and elastics. The patients were tasked with performing these exercises 10 times in each session and three times daily.

Control groupMobilization with movement

Each participant was tested with sustained manual glides in each of the possible directions during active wrist flexion and extension from the seated position. For the lateral glide, the therapist stabilises the lateral aspect of the distal radius using the first web-space. And glides the proximal row of carpal bones laterally (towards the thumb) using the first web-space of the other hand, following the joint line. For the medial glide, the therapist stabilises the medial aspect of the distal ulna using the first web-space. And glides the proximal row of carpal bones medially (away from the thumb) using the first web-space of the other hand, following the joint line.

Mobilization with movement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with distal radius fracture

You may not qualify if:

  • Patients with polytrauma,
  • open fracture,
  • ulnar head fracture (excluding ulnar styloid fracture),
  • history of complex regional pain syndrome,
  • limited cognitive capacity were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İsmail Ceylan

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Related Publications (2)

  • Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.

  • Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.

MeSH Terms

Conditions

PainAcute PainMobility Limitation

Interventions

Transcutaneous Electric Nerve StimulationExercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Investigator and Outcomes Assessor are different people. The Outcome Assessor was blind to groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of hand therapy clinic. PhD.

Study Record Dates

First Submitted

June 26, 2023

First Posted

August 4, 2023

Study Start

August 1, 2023

Primary Completion

November 10, 2023

Study Completion

November 13, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations