NCT03161782

Brief Summary

The aim of the study is to compare the efficacy of Proprioceptive Neuromuscular Facilitation (PNF) stretching and static stretching on range of motion (ROM), pain and function in elbow limitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

May 18, 2017

Last Update Submit

February 22, 2018

Conditions

Keywords

painexerciseproprioceptive neuromuscular facilitation stretchingstatic stretching

Outcome Measures

Primary Outcomes (1)

  • Functional Status

    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).

    After the six-week intervention

Secondary Outcomes (8)

  • Active Range of Motion (AROM) Assessment

    Baseline

  • Active Range of Motion (AROM) Assessment

    After the six-week intervention

  • Active Range of Motion (AROM) Assessment

    1-month follow up

  • Functional Status

    Baseline

  • Functional Status

    1-month follow up

  • +3 more secondary outcomes

Other Outcomes (7)

  • Quality of Life

    Baseline

  • Quality of Life

    After the six-week intervention

  • Quality of Life

    1-month follow up

  • +4 more other outcomes

Study Arms (2)

PNF Stretching group

EXPERIMENTAL

Each subject in PNF Stretching group will receive a treatment protocol consisting of PNF stretching, cold therapy and exercise.

Other: PNF stretchingOther: ExerciseOther: Cold Therapy

Static Stretching group

EXPERIMENTAL

Each subject in Static Stretching group will receive a treatment protocol consisting of static stretching, cold therapy and exercise.

Other: Static StretchingOther: ExerciseOther: Cold Therapy

Interventions

For hold-relax stretching, each subject in PNF Stretching group will be comfortably positioned in a supine lying position, and patient will move the joint to the end of the passive or pain-free ROM. The therapist will ask for an isometric contraction of the restricting muscle or pattern (antagonists) with emphasis on rotation. The patients will be asked to perform submaximal isometric contractions of the target muscle for 10 seconds. After the contraction, the patients will be instructed to relax for 5 seconds. The joint will be repositioned actively to the new limit of range, and then therapist will passively control the new ROM. The procedure will be repeated 10 times with 10 seconds of rest between two successive trials. Patients will be treated 2 times per week for 6 weeks.

PNF Stretching group

For static stretching, each subject in Static Stretching group will be comfortably positioned in a supine lying position, and the stretching of target muscle will be maintained for 20 seconds followed by 10 seconds of rest. The procedure will be repeated 10 times with 10 seconds of rest between two successive trials. Patients will be treated 2 times per week for 6 weeks.

Static Stretching group

Shoulder, elbow and wrist AROM exercises. Elbow flexion and extansion self-stretching exercises Elbow and wrist strengthening exercises Proprioception exercises for elbow. Grip strengthening exercises.

PNF Stretching groupStatic Stretching group

Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.

PNF Stretching groupStatic Stretching group

Eligibility Criteria

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

You may qualify if:

  • Subjectswill be included with
  • Aged between 18 and 65 years
  • Elbow fracture in the six months before the study
  • Elbow limitation in flexion or extension
  • Being volunteer to participate
  • Fractures should be managed with conservatively or surgically

You may not qualify if:

  • Malunion or Nonunion Fracture
  • Occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
  • Non-healing wound or infection
  • Previously received physiotherapy for elbow limitation
  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
  • Could not adjust to treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeElbow FracturesPainMotor Activity

Interventions

Muscle Stretching ExercisesExerciseCryotherapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsElbow InjuriesArm InjuriesWounds and InjuriesFractures, BoneBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tansu Birinci, MSc

    Istanbul University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

January 1, 2017

Primary Completion

May 15, 2017

Study Completion

July 25, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations