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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04696341
Other study ID # 25.01.2011/02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2011
Est. completion date May 6, 2011

Study information

Verified date January 2021
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thirty individuals with chronic neck pain randomised into two groups. Group I (15 subjects) received a total of 10 sessions as 5 sessions a week.Hot pack to cervical and upper thoracic regions (20 minutes), conventional Transcutaneous Electrical Nerve Stimulation (TENS) (100 Hz for 40 μsec), therapeutic ultrasound (1 Megahertz (MHz) for 5 minutes) and conventional massage were applied. Five sessions of Matrix Rhythm Therapy (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy Group II. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 minutes. Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm. Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm. Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. Turkish version of Beck Depression Inventory was used to assess emotional status of participants.


Description:

The study included patients aged between 25-65 years who had neck pain for at least 3 months. Patients with radiculopathy who had motor findings, who underwent any operations due to neck problems, who had systemic, neurologic and psychiatric diseases, inflammatory or infectious diseases, history of malignity, congenital anomalies, who benefited from another therapy modality and the ones in whom physical therapy modalities could not be used due to contraindications (individuals with sensory disorders, who use cardiac pace maker) were excluded from the study. A total of 36 individuals were randomly assigned into 2 groups. Randomization was allocated by numbered envelopes method. A total of 30 subjects (15 in Matrix Rhythm Therapy (MRT) group and 15 in CG) with neck pain due to mechanic causes like cervical discopathy, cervical arthrosis or myofascial pain syndrome were participated in this study. All assessments were done by the same physiotherapist (FU) before therapy and at the end of treatment sessions. The physiotherapist who did the assessments did not know to which group the subjects were belonged. Another physiotherapist who was not informed about the results of the evaluation treated the patients. Home-based exercise programs and recommendations were also given to patients. Matrix Rhythm Therapy is developed by Dr. Ulrich G. Randall at the university of Erlangen/Nuremberg. Longitudinal stroking, compression and spooning techniques are specific methods of MRT. Therapies of the patients were done by the physiotherapist who had certificate of MRT application.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 6, 2011
Est. primary completion date April 8, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Having neck pain for at least 3 months Exclusion Criteria: - radiculopathy with motor findings - undergoing surgical operation for neck pathologies - having a systemic , neurologic, psychiatric diseases - inflammatory or infectious diseases targeting this region - physical therapy modalities could not be used due to contraindications (individuals with sensory disorders, who use cardiac pace maker) - pregnancy - malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Matrix Rhythm Therapy
Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 µsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.Five sessions of MRT (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy to Matrix Rhythm Group. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 min (15 min for right and left sides each) according to the instructions of the technique developer.
Control
Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 µsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.

Locations

Country Name City State
Turkey Sarayköy Vocational School Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Smidt N, de Vet HC, Bouter LM, Dekker J, Arendzen JH, de Bie RA, Bierma-Zeinstra SM, Helders PJ, Keus SH, Kwakkel G, Lenssen T, Oostendorp RA, Ostelo RW, Reijman M, Terwee CB, Theunissen C, Thomas S, van Baar ME, van 't Hul A, van Peppen RP, Verhagen A, v — View Citation

Taspinar F, Aslan UB, Sabir N, Cavlak U. Implementation of matrix rhythm therapy and conventional massage in young females and comparison of their acute effects on circulation. J Altern Complement Med. 2013 Oct;19(10):826-32. doi: 10.1089/acm.2012.0932. E — View Citation

Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain). Higher scores mean a worse outcome. Baseline
Primary Muscle spasm Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm). Higher scores mean a worse outcome. Baseline
Primary Disability Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. NDI is composed of a total of 10 questions of which 4 about subjective symptoms Each section is scored between 0 and 5. For total scores 0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability Baseline
Primary Emotional status Turkish version of Beck Depression Inventory was used to assess emotional status of participants. Each question of the questionnaire which is composed of 21 questions is scored between 0 and 3. Higher scores than 17 mean risc for depression. Baseline
Secondary Pain intensity Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm 2 weeks
Secondary Muscle spasm Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm) 2 weeks
Secondary Disability Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. NDI is composed of a total of 10 questions of which 4 about subjective symptoms Each section is scored between 0 and 5 caused by neck pain. For total scores 0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability 2 weeks
Secondary Emotional status Turkish version of Beck Depression Inventory was used to assess emotional status of participants. Each question of the questionnaire which is composed of 21 questions is scored between 0 and 3. Higher scores than 17 means risc for depression. 2 weeks
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