- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03888586
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome (Dry Needling)
March 22, 2019 updated by: Başar Öztürk, Biruni University
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome: 1-year Follow-up of a Randomized Controlled Trial
This study was planned to investigate the effects of Trigger Point-Dry Needling Therapy (TP-DNT) on night pain and Shoulder Internal Rotation (SIR) in individuals with Subacromial Pain Syndrome (SPS).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Shoulder pain seen intensely in the general population, many methods has been used for the treatment which has not been fully proven to be superior to each other.
Before considering surgical approaches, trying conservative approaches is emphasized.
While literature showed us that nighttime pain is an important musculoskeletal symptom, may be associated with local inflammation, it is an important feature during the treatment planning.
TP-DNT had positive effects on night pain and SIR in SPS.
It was seen that the treatment satisfaction level of participants was high.
Despite these positive findings, there is need for further studies in which sample size is increased, control group is added, and long-term follow-up is planned.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Başar Öztürk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To be able to read and speak Turkish well enough to give informed consent and follow the working instructions.
- Having complaints of unilateral shoulder pain for at least 6 months and being diagnosed with subacromial impingement syndrome.
- Having night pain
- Having active trigger point.
Exclusion Criteria:
- Bilateral shoulder pain
- If there is a contraindicated condition for needles such as fear of needles or infection
- History of bleeding disorder
- Shoulder fracture and / or dislocation history
- Symptoms of cervical radiculopathy and / or neuropathy
- The use of antiaggregants, anticoagulants, analgesics or antiinflammatory drugs or drug-like substances (1 week before or during treatment)
- Fibromyalgia syndrome
- Any neurological, motor, or sensory disorder in the upper extremity
- History of surgery on shoulder or neck
- Conservative or invasive physical therapy or infiltration for the shoulder region during the last 6 months
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Dry Needling
Participants were administered trigger point dry kneedling technique 6 times for 1 month, once every 5 days.
The subject was positioned prone and the arm position was slightly changed related with the muscle.
After the skin inspection it was cleaned with the alcohol. .
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The type of needle and the depth of the entrance varied depending on the estimated muscle thickness (0.25 - 25 mm, 0.25 - 30 mm and 0.25-40 mm).
The disposable stainless-steel sterile needles were inserted through the skin over the trigger point in the taut band of muscle using the fast-in/out technique.
Forward and backward needling was repeated until the local twitch responses were obtained.
The depth of the needle was changed depending on the muscle thickness.
After the first local twitch response, the needle was moved up and down 3 to 5 mm in only vertical directions until no more local twitch responses were elicited.
After removing the needle, the insertion area was compressed with a piece of cotton
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EXPERIMENTAL: Deep Friction Massage
Deep friction massage was applied transversely unlike the superficial massage and sufficiently deep to the fiber direction of affected connective tissue to maintain the mobility.
Totally 6 sessions were administered twice a week for 3 weeks.
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For supporting the normal healing conditions, the deep and transverse friction causes hyperaemia in the involved soft tissue, which results in increased blood flow to the area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity
Time Frame: 1 month
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The VAS was used to measure the mean pain intensity of rest time activity and night time over the previous 3 days .
The 10-cm scale was marked with "0" (no pain) and "10" (worst imaginable pain), and the patients were instructed on how to use the scale.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Range of Motion
Time Frame: 1 month
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The goniometric measurement method measures the range of active internal movements of the internal rotation with pre-treatment and after 8 sessions.
The movement is repeated 3 times and recorded with the average.
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1 month
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Shoulder Pain and Disability Index (SPADI)
Time Frame: 1 month
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The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
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1 month
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1 month
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The HADS aims to measure symptoms of anxiety and depression and consists of 14 items, seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression).
HADS Anxiety focus mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression.
Each item is scored on a response-scale with four alternatives ranging between 0 and 3.
After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales.
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1 month
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Nothingham Health Profile
Time Frame: 1 month
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NHP is a general quality-of-life questionnaire that measures health problems that a person perceives and how these problems affect normal daily activities.
The questionnaire consists of 38 items and evaluates six dimensions of health status: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items) and physical activity (8 matter).
Questions are answered yes or no.
Each section is scored from 0 to 100 points.
0 indicates the best health status, 100 worst health status.
NHP score and total NHP score were evaluated.
Total NHP score was obtained from the sum of the sub-scores
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 2, 2017
Primary Completion (ACTUAL)
February 11, 2018
Study Completion (ACTUAL)
October 10, 2018
Study Registration Dates
First Submitted
March 22, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (ACTUAL)
March 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 22, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- manualpt2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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