AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Turkey (Türkiye)1 site
  • Rüstem Mustafaoğlu

    Istanbul, 34147

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04504409
Study groupRoleWhat they receive
Exercise group (ExG)Active comparatorThe 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)ExperimentalBefore 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 comparatorThe 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.

  1. 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

  2. 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)
  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.

  1. First posted7 Aug 2020
  2. Study start10 Aug 2020
  3. Primary completion25 Dec 2020
  4. Study completion10 Feb 2021

Resources

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)
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 17013824
  • Mitchell 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 16282408
  • Hidalgo-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 20186400
  • Bron 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in