Myofascial Pain SyndromesNCT04504409
Comparison of Efficacy of Dry Needling and Kinesio-taping
A study testing Rehabilitation in people with Myofascial Pain Syndromes, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the current study was to investigate the effects of KT and DN combined with exercise on pain, range of motion (ROM), and upper extremity function in patients with common shoulder disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2020to 10 Feb 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were eligible if they had unilateral non-traumatic shoulder pain (described as pain felt in the shoulder or upper arm) for at least six months, were between ages 18-60 years, and diagnosed with at least one active MTrP in shoulder region.
Who cannot join
- Patients who have been diagnosed with shoulder instability, shoulder fractures, neurological diseases, or other severe medical or psychiatric disorders will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Dry Needling and Kinesio-taping on Myofascial Trigger Points in Patients With Common Shoulder Disorders
The aim of the current study was to investigate the effects of KT and DN combined with exercise on pain, range of motion (ROM), and upper extremity function in patients with common shoulder disorders.
Read the detailed description
Shoulder pain is a common musculoskeletal problem seen in working population. The main contributor to nontraumatic upper-limb pain, in which chronicity and recurrence of symptoms are common. A common cause of muscle pain is myofascial pain caused by myofascial trigger points (MTrPs). Travel and Simons have described trigger points as 'a tender point on palpation characterized by referring pain, motor dysfunction and autonomic symptoms and usually located in the taut band or the fascia of the muscle. MTrPs in the shoulder muscles produce symptoms similar to those of other shoulder pain syndromes, including pain at rest and with movement, sleep disturbances and pain provocation during impingement tests. MTrPs are classified into active and latent trigger points. An active MTrP causes a clinical pain complaint. It is always tender, prevents full lengthening of the muscle, weakens the muscle, refers a patient-recognized pain on compression, mediates a local twitch response of muscle fibers when adequately stimulated and, when compressed within the patient's pain tolerance, produces referred motor phenomena and often autonomic phenomena, generally in its pain reference zone, and causes tenderness in the pain reference zone. A latent MTrP is clinically quiescent with respect to spontaneous pain; it is painful only when palpated. A latent MTrP may have all the other clinical characteristics of an active MTrP and always has a taut band that increases muscle tension and restricts range of motion. An alternative approach to the management of persons with shoulder problems consists of a treatment aimed at inactivating MTrPs and eliminating factors that perpetuate them. Manual techniques (such as compression on the trigger point or other massage techniques), cooling the skin with ethyl chloride spray and stretch and trigger point needling can inactivate MTrPs. MTrP inactivation may be combined with active exercises, postural correction, extracorporeal shock wave therapy, kinesio taping and relaxation if and when appropriate. Kinesio taping (KT) and dry needling (DN) are two common applications being used in treatment of acute and chronic musculoskeletal problems in recent years. Several therapies have been proposed for MTrPs, including KT, a relatively new method that has become widely used as a therapeutic tool in a variety of prevention and rehabilitation protocols. KT is an elastic cotton adhesive tape which is latex-free and can be used on any joint or muscle. Te exact mechanism by which KT functions remain unknown, though it is thought that its effectiveness may be mediated by cutaneous mechanoreceptors which would provide sensorimotor and proprioceptive feedback, and/or by mechanical restraint and inhibitory and excitatory nociceptive stimuli [16]. Various groups have shown that the use of KT can be beneficial, for example, by decreasing pain or by increasing range of motion (ROM) in shoulder pathologies. Among the non-pharmacological options, DN, despite the controversy, is currently considered one of the most effective interventions for the direct inactivation of MTrPs and is gaining attention for the treatment of MTrPs in musculoskeletal pain by targeting trigger points and non- trigger point structures. It is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying trigger points, muscular and connective tissues without the use of injectate. A systematic review with meta-analysis reported that DN, compared with sham/placebo, can decrease pain immediately after treatment and in four weeks among patients with upper quarter myofascial pain syndrome. Another systematic review with metaanalysis reported that DN can be recommended to relieve MTrP pain of neck and shoulders in short and medium terms, but wet needling is more effective than DN in reducing MTrP pain in neck and shoulders in medium term.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Rehabilitation
- Keywords
- shoulder pain, myofascial trigger point, dry needling, kinesio tape, exercise
- Medical subject headings
- Myofascial Pain Syndromes, Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Training
| Study group | Role | What they receive |
|---|---|---|
| Exercise group (ExG) | Active comparator | The exercise program consisted of; Codman , wand, stretching and strengthening exercises [25] applied twice a day, 5 times a week and duration of 3 weeks in all groups. All exercises were performed for 10 repetitions and 3 sets. Patients performed exercises with under supervision of physiotherapist in the clinic settings. In ExG, patients received only this exercise protocol for 3-weeks. Receives: Other: Rehabilitation |
| KT application combined with exercise (KTG) | Experimental | Before KT application, their skin was shaved, cleaned with alcohol, and dried. Prior to application, the patient was seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side. KTs (Ares®) tape was used. The first strip was a Y-strip representative of the supraspinatus, which was applied from its insertion to origin with paper off tension. A Y-strip refers to a section of tape that has a portion cut down the middle to produce 2 tails. In KTG, patients wore the KT for a 3-week duration (renewed twice a week periodically in this time). Receives: Other: Rehabilitation |
| DN combined with exercise (DNG) | Active comparator | The MTrP dry needling procedure employed was similar to the MTrP injection described by Hong. The MTrP was located by palpating the taut band and identifying the point of maximal tenderness. This was then firmly compressed by the index finger or middle finger of the nondominant hand to direct the placement of the needle tip while inserting the needle. The needle was inserted into the skin at a point above the taut band, approximately 1 cm from the MTrP region. After penetration of the needle into the subcutaneous layer, it was kept there and obliquely (about 45 degrees) directed to the MTrP region under the fingertip of the non-dominant hand. Then, the needle was inserted rapidly into the MTrP region and withdrawn rapidly. In DNG, patients received DN for a 3-week duration (twice a week periodically in this time). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity was assessed using the Visual Analog Scale (VAS), in which the patient is asked to indicate his/her perceived pain during rest, activity and at night (0-10 VAS, with 0 as no pain and 10 as worst imaginable pain.
Measured: 3-weeks
Range of Motion
Limited and painful ROM is often observed in patients with shoulder disorders. Shoulder active ROM was measured in a supine position using a universal goniometer. The goniometer is a reliable instrument for measuring shoulder ROM . All measurements will be taken with patients standing. In this study, three repetitions were performed in each direction, and the average of three trials will determine the mean ROM values for each condition.
Measured: 3-weeks
Secondary outcomes (1)
Upper extremity functions
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item scale of disability symptoms used to assess a patient's health status. The scores obtained from all items are then used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start10 Aug 2020
- Primary completion25 Dec 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rüstem Mustafaoğlu, Istanbul University - Cerrahpasa
- Investigators
- Rüstem Mustafaoğlu, Principal investigator, İstanbul Üniversitesi, Sağlık Bilimleri Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504409
- Sponsor's protocol ID
- 127
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.
PubMed 17013824Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PubMed 16282408Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
PubMed 20186400Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
PubMed 21711512
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Dry Needling and Kinesio-taping on Myofascial Trigger Points in Patients With Common Shoulder Disorders
- ClinicalTrials.gov ID
- NCT04504409
- Acronym / sponsor ID
- 127
- Conditions
- Myofascial Pain Syndromes
- Keywords
- shoulder pain, myofascial trigger point, dry needling, kinesio tape, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 7 Aug 2020 (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.
The aim of the current study was to investigate the effects of KT and DN combined with exercise on pain, range of motion (ROM), and upper extremity function in patients with common shoulder disorders.
Detailed description
Shoulder pain is a common musculoskeletal problem seen in working population. The main contributor to nontraumatic upper-limb pain, in which chronicity and recurrence of symptoms are common. A common cause of muscle pain is myofascial pain caused by myofascial trigger points (MTrPs). Travel and Simons have described trigger points as 'a tender point on palpation characterized by referring pain, motor dysfunction and autonomic symptoms and usually located in the taut band or the fascia of the muscle. MTrPs in the shoulder muscles produce symptoms similar to those of other shoulder pain syndromes, including pain at rest and with movement, sleep disturbances and pain provocation during impingement tests. MTrPs are classified into active and latent trigger points. An active MTrP causes a clinical pain complaint. It is always tender, prevents full lengthening of the muscle, weakens the muscle, refers a patient-recognized pain on compression, mediates a local twitch response of muscle fibers when adequately stimulated and, when compressed within the patient's pain tolerance, produces referred motor phenomena and often autonomic phenomena, generally in its pain reference zone, and causes tenderness in the pain reference zone. A latent MTrP is clinically quiescent with respect to spontaneous pain; it is painful only when palpated. A latent MTrP may have all the other clinical characteristics of an active MTrP and always has a taut band that increases muscle tension and restricts range of motion. An alternative approach to the management of persons with shoulder problems consists of a treatment aimed at inactivating MTrPs and eliminating factors that perpetuate them. Manual techniques (such as compression on the trigger point or other massage techniques), cooling the skin with ethyl chloride spray and stretch and trigger point needling can inactivate MTrPs. MTrP inactivation may be combined with active exercises, postural correction, extracorporeal shock wave therapy, kinesio taping and relaxation if and when appropriate. Kinesio taping (KT) and dry needling (DN) are two common applications being used in treatment of acute and chronic musculoskeletal problems in recent years. Several therapies have been proposed for MTrPs, including KT, a relatively new method that has become widely used as a therapeutic tool in a variety of prevention and rehabilitation protocols. KT is an elastic cotton adhesive tape which is latex-free and can be used on any joint or muscle. Te exact mechanism by which KT functions remain unknown, though it is thought that its effectiveness may be mediated by cutaneous mechanoreceptors which would provide sensorimotor and proprioceptive feedback, and/or by mechanical restraint and inhibitory and excitatory nociceptive stimuli [16]. Various groups have shown that the use of KT can be beneficial, for example, by decreasing pain or by increasing range of motion (ROM) in shoulder pathologies. Among the non-pharmacological options, DN, despite the controversy, is currently considered one of the most effective interventions for the direct inactivation of MTrPs and is gaining attention for the treatment of MTrPs in musculoskeletal pain by targeting trigger points and non- trigger point structures. It is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying trigger points, muscular and connective tissues without the use of injectate. A systematic review with meta-analysis reported that DN, compared with sham/placebo, can decrease pain immediately after treatment and in four weeks among patients with upper quarter myofascial pain syndrome. Another systematic review with metaanalysis reported that DN can be recommended to relieve MTrP pain of neck and shoulders in short and medium terms, but wet needling is more effective than DN in reducing MTrP pain in neck and shoulders in medium term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise group (ExG) | Active comparator | Other: RehabilitationThe exercise program consisted of; Codman , wand, stretching and strengthening exercises [25] applied twice a day, 5 times a week and duration of 3 weeks in all groups. All exercises were performed for 10 repetitions and 3 sets. Patients performed exercises with under supervision of physiotherapist in the clinic settings. In ExG, patients received only this exercise protocol for 3-weeks. |
| KT application combined with exercise (KTG) | Experimental | Other: RehabilitationBefore KT application, their skin was shaved, cleaned with alcohol, and dried. Prior to application, the patient was seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side. KTs (Ares®) tape was used. The first strip was a Y-strip representative of the supraspinatus, which was applied from its insertion to origin with paper off tension. A Y-strip refers to a section of tape that has a portion cut down the middle to produce 2 tails. In KTG, patients wore the KT for a 3-week duration (renewed twice a week periodically in this time). |
| DN combined with exercise (DNG) | Active comparator | Other: RehabilitationThe MTrP dry needling procedure employed was similar to the MTrP injection described by Hong. The MTrP was located by palpating the taut band and identifying the point of maximal tenderness. This was then firmly compressed by the index finger or middle finger of the nondominant hand to direct the placement of the needle tip while inserting the needle. The needle was inserted into the skin at a point above the taut band, approximately 1 cm from the MTrP region. After penetration of the needle into the subcutaneous layer, it was kept there and obliquely (about 45 degrees) directed to the MTrP region under the fingertip of the non-dominant hand. Then, the needle was inserted rapidly into the MTrP region and withdrawn rapidly. In DNG, patients received DN for a 3-week duration (twice a week periodically in this time). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients were eligible if they had unilateral non-traumatic shoulder pain (described as pain felt in the shoulder or upper arm) for at least six months, were between ages 18-60 years, and diagnosed with at least one active MTrP in shoulder region.
Key exclusion criteria (1 listed)
- Patients who have been diagnosed with shoulder instability, shoulder fractures, neurological diseases, or other severe medical or psychiatric disorders will be excluded from the study.
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 |
|---|---|---|
| RehabilitationTraining | Other | DN combined with exercise (DNG), Exercise group (ExG), KT application combined with exercise (KTG) |
Primary outcome
Pain intensity
Time frame: 3-weeks
Pain intensity was assessed using the Visual Analog Scale (VAS), in which the patient is asked to indicate his/her perceived pain during rest, activity and at night (0-10 VAS, with 0 as no pain and 10 as worst imaginable pain.
Range of Motion
Time frame: 3-weeks
Limited and painful ROM is often observed in patients with shoulder disorders. Shoulder active ROM was measured in a supine position using a universal goniometer. The goniometer is a reliable instrument for measuring shoulder ROM . All measurements will be taken with patients standing. In this study, three repetitions were performed in each direction, and the average of three trials will determine the mean ROM values for each condition.
1 secondary outcome
Upper extremity functions
Time frame: 3-weeks
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 5 Aug 2021.
- Results publication: PubMed 17013824Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.
- Results publication: PubMed 16282408Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
- Results publication: PubMed 20186400Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
- Results publication: PubMed 21711512Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
- Individual participant dataSharing planned: No
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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.
Rüstem Mustafaoğlu principal investigator
İstanbul Üniversitesi, Sağlık Bilimleri Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Myofascial Pain Syndromes, run by Istanbul University - Cerrahpasa 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 1 inclusion and 1 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 5 Aug 2021. 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: 3-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504409, which also lists 4 linked publications.
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 5 Aug 2021.