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Dry Needling and Exercise for Frozen Shoulder
N/A
Waitlist Available
Led By Derek Clewley, DPT, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Glenohumeral passive range of motion limited in multiple directions
Age 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-week, 1-month, 6-months
Awards & highlights
Study Summary
This trial will compare the two groups to see if adding dry needling to exercise is more effective in treating shoulder adhesive capsulitis than exercise alone.
Who is the study for?
This trial is for adults aged 18-65 with shoulder pain and stiffness from adhesive capsulitis, also known as frozen shoulder. Participants must have limited shoulder motion, a pain level of at least 2/10 during normal activity, and be able to read and speak English. People with neck-related symptoms, other shoulder conditions, recent needling treatments, fear of needles, on anticoagulants or extreme scores on the Shoulder Pain and Disability Index are excluded.Check my eligibility
What is being tested?
The study tests if adding dry needling to exercise therapy improves outcomes in treating frozen shoulder. Participants will be randomly assigned to two groups: one receiving real dry needling at specific trigger points around the affected area; the other getting sham (fake) needle treatment at those same points.See study design
What are the potential side effects?
Dry needling can cause side effects like temporary soreness or bruising where the needles are inserted. Some people might feel faint or experience an aggravation of symptoms initially after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have limited shoulder movement in several directions.
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I am between 18 and 65 years old.
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My pain level during normal activities is 2 or more out of 10.
Select...
I am experiencing shoulder pain and stiffness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-week, 1-month, 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-week, 1-month, 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Shoulder Pain and Disability Index Change
Secondary outcome measures
Numeric Pain Rating Scale Change
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dry needling and exerciseExperimental Treatment2 Interventions
Group II: Sham dry needling and exercisePlacebo Group2 Interventions
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,969 Total Patients Enrolled
Derek Clewley, DPT, PhDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have limited shoulder movement in several directions.My shoulder movement is limited when I lift my arm sideways.Your doctor has found evidence of a different shoulder problem during the examination.Your shoulder pain and disability index (SPADI) score is too low (less than 10%) or too high (greater than 90%).My symptoms appeared slowly over time.My shoulder moves normally without pain or assistance.I have pain or symptoms that suggest a nerve issue in my neck.I have had dry needling or acupuncture in the last 6 months.I am between 18 and 65 years old.I have shoulder arthritis confirmed by an X-ray.My pain level during normal activities is 2 or more out of 10.I am currently on blood thinner medication.You are afraid of needles.I am experiencing shoulder pain and stiffness.I have a diagnosed neurological condition.
Research Study Groups:
This trial has the following groups:- Group 1: Dry needling and exercise
- Group 2: Sham dry needling and exercise
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research venture accessible to participants presently?
"The clinicaltrials.gov website shows that, while this research study was first launched on October 13th 2020, it is not currently seeking participants. However, there are 103 other trials which require patient enrolment right now."
Answered by AI
What are the qualifications for individuals hoping to participate in this clinical trial?
"This clinical study is seeking 100 volunteers, aged 18 to 65 years old, who experience shoulder pain and stiffness. To be eligible for the trial participants must: have a primary complaint of shoulder-related discomfort; describe symptoms with gradual onset; demonstrate limited glenohumeral passive range of motion when abducting humerus from 45 degrees to 90 degrees; report pain levels at or greater than 2/10 on numeric pain rating scale; comprehend English language."
Answered by AI
Does this trial accept participants aged 18 and above?
"This medical experiment is open to participants aged 18-65, but there are a total of 85 trials for patients outside that range; 3 studies for those under 18 and 82 studies for those over 65."
Answered by AI
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