Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 51 for:    "Frozen Shoulder"

Dry Needling for Shoulder Adhesive Capsulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03861923
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study evaluates the addition of dry needling to exercise as part of physical therapy for the treatment of shoulder adhesive capsulitis. There will be two groups. One will receive actual dry needling to the clinically determined shoulder / parascapular trigger points. The other group will receive a sham needle treatment to the clinically determined areas.

Condition or disease Intervention/treatment Phase
Shoulder Adhesive Capsulitis Shoulder Pain Frozen Shoulder Other: Dry needling Other: Sham Dry Needling Other: Therapeutic Exercise Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Dry Needling on Pain and Function for the Management of Shoulder Adhesive Capsulitis: a Randomized Controlled Trial
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dry needling and exercise Other: Dry needling
Trigger point dry needling to trigger points in the shoulder or parascapular muscles using monofilament needle (i.e., acupuncture needle). Clean needle approach using sterile needles.
Other Name: Trigger Point Dry Needling

Other: Therapeutic Exercise
Exercise including flexibility, range of motion, strengthening will be provided by the treating physical therapist based on the impairments identified.
Other Name: Exercise

Sham Comparator: Sham dry needling and exercise Other: Sham Dry Needling
Sham needle approach using a finishing nail in a tube sheath. The finishing nail will be placed over the trigger point so that the patient perceives a sharp sensation. The tube (not the nail) will be moved up and down to mimic the action of needling.

Other: Therapeutic Exercise
Exercise including flexibility, range of motion, strengthening will be provided by the treating physical therapist based on the impairments identified.
Other Name: Exercise




Primary Outcome Measures :
  1. Shoulder Pain and Disability Index Change [ Time Frame: 1-week, 1-month, 6-months ]
    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire. Two dimensions are measured, one for pain and the other for functional activities. The pain dimension includes five questions to determine the severity of an individual's pain. The functional activities are assessed with eight questions. The two dimensions are combined into one score. Scores range from 0 to 100 with scores closer to 0 indicating lower (or no) disability and scores closer to 100 indicating greater disability. It takes 5 to 10 minutes for a patient to complete.


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale Change [ Time Frame: 1-week, 1-month, 6- months ]
    The numeric pain rating scale (NPRS) is an 11 point scale scored between "0" (no pain) and "10" (the most intense pain imaginable). Individuals select a value that is most in the with the intensity of pain they've experienced in the past 24 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary complaint of shoulder pain and stiffness
  • Gradual onset of symptoms
  • Glenohumeral passive range of motion limited in multiple directions
  • Glenohumeral passive range of motion decreases as the humerus is abducted from 45 degrees to 90 degrees
  • Age 18 to 65 years
  • Reports pain with normal activity greater than or equal to 2/10 on the numeric pain rating scale
  • Read and speak English

Exclusion Criteria:

  • Signs or symptoms of cervical radiculopathy, radiculitis, or referral from the cervical spine
  • Clinical evidence as determined in the examination of an alternative shoulder diagnosis
  • Normal passive shoulder range of motion
  • Known radiographic evidence of glenohumeral osteoarthritis
  • Known neurologic disease
  • Received dry needling or acupuncture within the past 6 months
  • Fear of needling
  • Currently being treated with anticoagulant medication
  • Shoulder pain and disability index (SPADI) score less than 10% or greater than 90%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861923


Contacts
Layout table for location contacts
Contact: Derek Clewley, DPT, PhD 9196139053 derek.clewley@duke.edu
Contact: Heather Myers, DPT 919-681-1656 heather.myers@duke.edu

Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Derek Clewley, DPT, PhD Duke University

Publications:

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03861923     History of Changes
Other Study ID Numbers: PRO00101726
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
dry needling
physical therapy
trigger point

Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Bursitis
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms