Subacromial Impingement SyndromeDry NeedlingNCT03888586
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome
A study testing Trigger Point Dry Needling Technique and Deep Friction Massage Technique in people with Subacromial Impingement Syndrome and Trigger Point Pain, Myofascial, run by Biruni University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- Trigger Point Dry Needling Technique and Deep Friction Massage Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2017to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Trigger Point Dry Needling Technique, Deep Friction Massage Technique
- Keywords
- Dry needling, subacromial joint, night pain
- Medical subject headings
- Shoulder Impingement Syndrome, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger Point Dry Needling TechniqueDevice
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
Deep Friction Massage TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | 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. . Receives: Device: Trigger Point Dry Needling Technique |
| Deep Friction Massage | Experimental | 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. Receives: Other: Deep Friction Massage Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start2 Oct 2017
- Primary completion11 Feb 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Başar Öztürk, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888586
- Sponsor's protocol ID
- manualpt2019
- Acronym
- Dry Needling
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03888586
- Acronym / sponsor ID
- Dry Needling / manualpt2019
- Keywords
- Dry needling, subacromial joint, night pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 11 Feb 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Trigger Point Dry Needling TechniqueParticipants 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 | Experimental | Other: Deep Friction Massage TechniqueDeep 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigger Point Dry Needling TechniqueThe 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 | Device | Dry Needling |
| Deep Friction Massage TechniqueFor 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. | Other | Deep Friction Massage |
Primary outcome
Pain Intensity
Time frame: 1 month
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.
4 secondary outcomes
Range of Motion
Time frame: 1 month
Shoulder Pain and Disability Index (SPADI)
Time frame: 1 month
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 month
Nothingham Health Profile
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger Point Dry Needling Technique and Deep Friction Massage Technique in people with Subacromial Impingement Syndrome and Trigger Point Pain, Myofascial, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.