NCT06088667

Brief Summary

Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 12, 2023

Last Update Submit

October 10, 2024

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

  • Pain severity

    Visuel analog scale will be used to evaluate individuals' shoulder pain level.

    baseline and 4 weeks post-intervention

Secondary Outcomes (3)

  • Range of motion

    baseline and 4 weeks post-intervention

  • Kinesiophobia

    baseline and 4 weeks post-intervention

  • Functional level

    baseline and 4 weeks post-intervention

Study Arms (2)

Fascial mobilization group

EXPERIMENTAL

In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments.

Other: Fascial mobilization group

Control Group

EXPERIMENTAL

The control group will receive heat application, electrical stimulation and shoulder exercises for 4 weeks.

Other: Fascial mobilization group

Interventions

Fascial mobilization groupOTHER

In addition to the rehabilitation given to the control group, the fascial release group will be treated with the Graston device to the superficial and deep fascia of the neck and shoulder muscles, biceps and triceps brachii muscles and forearm compartments for 4 weeks.

Control GroupFascial mobilization group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years old
  • weeks have passed since arthroscopic rotator cuff repair

You may not qualify if:

  • cervical discopathy,
  • shoulder osteoarthritis
  • fracture or tumor of the upper extremity,
  • adhesive capsulitis,
  • shoulder instability,
  • thoracic outlet syndrome and
  • patients with neurological or mental problems.
  • Non-voluntary patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location

Related Publications (3)

  • Pegreffi F, Paladini P, Campi F, Porcellini G. Conservative management of rotator cuff tear. Sports Med Arthrosc Rev. 2011 Dec;19(4):348-53. doi: 10.1097/JSA.0b013e3182148dc6.

    PMID: 22089284BACKGROUND

  • Nikolaidou O, Migkou S, Karampalis C. Rehabilitation after Rotator Cuff Repair. Open Orthop J. 2017 Feb 28;11:154-162. doi: 10.2174/1874325001711010154. eCollection 2017.

    PMID: 28400883BACKGROUND

  • Coban T, Demirdel E, Yildirim NU, Deveci A. The investigation of acute effects of fascial release technique in patients with arthroscopic rotator cuff repair: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101573. doi: 10.1016/j.ctcp.2022.101573. Epub 2022 Mar 21.

    PMID: 35397305RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

October 15, 2023

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)