NCT03613922

Brief Summary

The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Patients were randomly divided into two groups: Routin Physiotherapy (RP) or Early Manual Therapy (EMT). While RP group received routine physiotherapy, EMT group received routine physiotherapy plus Mulligan's Mobilization With Movement technique. All treatments were done two sessions a week, through 12 weeks. Function, pain, range of motion (ROM), hand and pinch grip strength and disability level of patients were assessed. Measurements were made at postoperative week 3, 6 and 12.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

July 26, 2018

Last Update Submit

November 12, 2018

Conditions

Keywords

manual therapyradius fracturefunctiondisabilityphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • change in the function

    Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)

    postoperative week 6, 12.

Secondary Outcomes (4)

  • change in the severity of pain

    postoperative day 1, postoperative week 3, 6, 12.

  • change in the range of motion (ROM)

    postoperative week 3, 6, 12.

  • change in hand and pinch grip strength

    postoperative week 3, 6, 12.

  • change in disability

    postoperative week 6, 12.

Study Arms (2)

Early Manual Therapy Group

EXPERIMENTAL

Routine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied.

Other: Early Manual TherapyOther: Routine Physiotherapy

Routine Physiotherapy Group

ACTIVE COMPARATOR

Only routine physiotherapy program was applied

Other: Routine Physiotherapy

Interventions

Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.

Early Manual Therapy Group

Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.

Early Manual Therapy GroupRoutine Physiotherapy Group

Eligibility Criteria

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

You may qualify if:

  • An age of eighteen years or older
  • An unstable fracture of the distal end of the radius
  • Fixation with a volar locking plate
  • Able to read, write, and understand Turkish
  • Willing and able to attend the study

You may not qualify if:

  • Previous fracture on the injured side
  • Concurrent fracture in contralateral upper extremity
  • Accompanied bony and soft tissue injuries other than radius fracture
  • Inflammatory joint diseases, metabolic diseases and neurological diseases
  • Mental and cognitive disorders that would seriously affect cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist FracturesRadius Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneForearm Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 3, 2018

Study Start

September 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations