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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04504409
Other study ID # 127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2020
Est. completion date February 10, 2021

Study information

Verified date August 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date February 10, 2021
Est. primary completion date December 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation
Training

Locations

Country Name City State
Turkey Rüstem Mustafaoglu Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Hidalgo-Lozano A, Fernández-de-las-Peñas 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 st — View Citation

Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3-weeks
Primary 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. 3-weeks
Secondary 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). 3-weeks
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