NCT05358730

Brief Summary

This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 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

March 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

October 8, 2024

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

April 28, 2022

Last Update Submit

October 5, 2024

Conditions

Keywords

Adhesive capsulitisFunctionPainExercise

Outcome Measures

Primary Outcomes (1)

  • Upper extremity function

    DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.

    Baseline

Secondary Outcomes (14)

  • Upper extremity function

    At the end of the 3-week intervention

  • Upper extremity function

    At the end of the 6-week intervention

  • The severity of pain

    Baseline

  • The severity of pain

    At the end of the 3-week intervention

  • The severity of pain

    At the end of the 6-week intervention

  • +9 more secondary outcomes

Study Arms (2)

IASTM + Standard Exercise Group

EXPERIMENTAL

Patients were applied IASTM in combination with standard exercise program two days a week for six weeks. The IASTM technique was performed using six titanium-plated instruments in different sizes, shapes and treatment styles. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment.

Other: Standard ExerciseOther: Instrument Assisted Soft Tissue Mobilization (IASTM)Other: Home Exercise

Standard Exercise Group

ACTIVE COMPARATOR

Patients were given a standard exercise program two days a week for six weeks. ROM, crutch, roller, scapulothoracic and stretching exercises were given as home exercises during the treatment.

Other: Standard ExerciseOther: Home Exercise

Interventions

Glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises were performed under the supervision of a physiotherapist two days per week for six weeks at the clinical setting (Celik and Kaya Mutlu, 2016).

IASTM + Standard Exercise GroupStandard Exercise Group

IASTM treatment was applied to the posterior-anterior-middle deltoid, latissimus dorsi, teres major, teres minor, supraspinatus and infraspinatus muscle fibers, superficial and deep fascia. IASTM was applied in parallel and vertical direction to the muscle fibers treated with the instrument at a 45° angle, each technique (SWEEP, BRUSH (straight short steps) techniques) for 20 seconds (Ikeda, Otsuka, Kawanishi, and Kawakami, 2019). It was performed two days per week for six weeks.

IASTM + Standard Exercise Group

Hme exercise program consisted of glenohumeral exercises, scapulothoracic exercises, stretching exercises and mobilization exercises. It was asked to perform two days per week for six weeks.

IASTM + Standard Exercise GroupStandard Exercise Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 30 and 65 years;
  • Duration of complaint of more than three months
  • ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions

You may not qualify if:

  • Having cervical radiculopathy
  • Thoracic outlet syndrome
  • Rheumatological disorders
  • Fractures or tumors of either upper extremity
  • Corticosteroid injections in the affected shoulder within the previous 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder PainTissue AdhesionsFacial PainBursitisPainMotor Activity

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCicatrixFibrosisPathologic ProcessesBehavior

Study Officials

  • Tansu Birinci, PT, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

March 10, 2019

Primary Completion

August 10, 2019

Study Completion

December 20, 2019

Last Updated

October 8, 2024

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations