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Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome (Dry Needling)

Primary Purpose

Subacromial Impingement Syndrome, Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Trigger Point Dry Needling Technique
Deep Friction Massage Technique
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Dry needling, subacromial joint, night pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Başar Öztürk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dry Needling

Deep Friction Massage

Arm Description

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. .

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.

Outcomes

Primary Outcome Measures

Pain Intensity
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.

Secondary Outcome Measures

Range of Motion
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.
Shoulder Pain and Disability Index (SPADI)
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.
Hospital Anxiety and Depression Scale (HADS)
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.
Nothingham Health Profile
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

Full Information

First Posted
March 22, 2019
Last Updated
March 22, 2019
Sponsor
Biruni University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03888586
Brief Title
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome
Acronym
Dry Needling
Official Title
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome: 1-year Follow-up of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
February 11, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome, Trigger Point Pain, Myofascial
Keywords
Dry needling, subacromial joint, night pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
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. .
Arm Title
Deep Friction Massage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Trigger Point Dry Needling Technique
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Deep Friction Massage Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Range of Motion
Description
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.
Time Frame
1 month
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
1 month
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
1 month
Title
Nothingham Health Profile
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Başar Öztürk
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome

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