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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03949010
Other study ID # KSCT&KMIT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date December 2014

Study information

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

Clinical Trial Summary

To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.


Description:

The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only. Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales. Statistical tests were conducted at the 0.05 significance level for all outcome measures.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- being female

- being aged between 18 and 45 years old

- not being in menopausal period

- having pain in upper trapezius region

- determining a taut band in examination

- having at least one active TP in this taut band

- the pain produced by palpation of this TP is the pain that the patient complains

- painfull restriction of cervical lateral flexion

- having pain score 4 or more according to NRS

- signing informed consent.

Exclusion Criteria:

- having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)

- having any operative history including the head and neck region

- having a neuromuscular disease

- having an active rheumatic disease

- having a systemic disease (diabetes, hypothyroidism, infection, malignancy...)

- having any pathology related to musculoskeletal diseases -especially including the cervical region- (cervical discopathy, cervical spondylosis, pathologies related to shoulder joint and surrounding soft tissues, scoliosis, kyphosis, limb length discrepancy, polio sequelae, developmental hip dysplasia...)

- having serious psychological problems (having score of 30 or more from Beck Depression Inventory)

- being obese (Body Mass Index=30 kg/m2)

- having allergy to kinesiotapes

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesiotaping with space correction technique
Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program
Kinesiotaping with muscle inhibition technique
Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program
Home exercise program
Home exercise program which consists of stretching exercises towards neck area

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dilsad Sindel

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity Initial assessment, First week, second week, sixth week
Primary Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks Functional status measurement via Neck Disability Index Initial assessment, second week, sixth week
Primary Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks Quality of life measurement via Short Form-36 Initial assessment, second week, sixth week