NCT03705975

Brief Summary

This study aim was to compare the effectiveness of manual treatment and proprioceptive neuromuscular fasilitation (PNF) techniques in patients with adhesive capsulitis. One group will receive classical physical therapy including hotpack,ultrason and in additon manual treatment application. Other group receive classical physical therapy including hotpack, ultrason and in addition PNF techniques. Two group will be made wand exercise at home three times a day 10 times at one session.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

April 16, 2019

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

September 19, 2018

Last Update Submit

April 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Range of motion change

    Flexion, abduction, internal and external rotation range of motion will assessed with universal goniometer.

    change from baseline range of motion assessment at 8 weeks

Secondary Outcomes (10)

  • Subjective pain assessment: VAS

    Change from baseline subjective pain assessment at 8 weeks

  • Scapular dyskinesis

    Change from baseline scapular dyskinesis assessment at 8 weeks

  • Muscle strenght

    Change from baseline muscle strenght assessment at 8 weeks

  • General arm function

    Change from baseline shoulder function assessment at 8 weeks

  • Health quality depent on health

    Change from baseline health quality assessment at 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

edit arms

ACTIVE COMPARATOR

classical physiotherapy and manual treatment. Classical physiotherapy consisting of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Manual treatment is consist of scapular mobilization, glenohumeral joint inferior and posterior mobilization. Treatment modality is implemented by physical therapist three times a week for 8 weeks.

Other: Manual treatment

edit arm/intervention cross

ACTIVE COMPARATOR

classical physiotherapy and proprioceptive neuromusculer fasilitation. Classical physiotherapy consist of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Scapular PNF and upper extremity PNF (flexion-abduction-external rotation) pattern. Treatment programme was implemented by physical therapist three times a week for 8 weeks.

Other: Manual treatment

Interventions

Scapula mobilization, glenohumeral joint mobilization

edit arm/intervention crossedit arms

Eligibility Criteria

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

You may qualify if:

  • adhesive capsulitis due to idiopathic or acquired reasons

You may not qualify if:

  • Cervical disk hernia
  • Neuromusculer disease
  • Shoulder impingement syndrome
  • Rotator cuff tear
  • Corticosteroid enjeksion in shoulder
  • Tumour
  • Physical therapy or manual treatment is implemented same shoulder last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kübra

Ankara, Sıhhıye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 19, 2018

First Posted

October 15, 2018

Study Start

November 1, 2018

Primary Completion

April 18, 2019

Study Completion

April 20, 2019

Last Updated

April 16, 2019

Record last verified: 2018-06

Locations