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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03888586
Other study ID # manualpt2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2017
Est. completion date October 10, 2018

Study information

Verified date March 2019
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 10, 2018
Est. primary completion date February 11, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Device:
Trigger Point Dry Needling Technique
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
Other:
Deep Friction Massage Technique
For supporting the normal healing conditions, the deep and transverse friction causes hyperaemia in the involved soft tissue, which results in increased blood ?ow to the area.

Locations

Country Name City State
Turkey Basar Öztürk Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Biruni University Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
Secondary 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. 1 month
Secondary 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. 1 month
Secondary 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. 1 month
Secondary 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 1 month
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