- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696341
The Effect of Matrix Rhythm Therapy in Patients With Chronic Neck Pain
The Effectiveness of a Novel Massage Method Matrix Rhythm Therapy in Chronic Neck Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey, 20300
- Sarayköy Vocational School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Matrix Rhythm Therapy
Group I (15 subjects) received 10 sessions as 5 sessions a week.
Hot pack to cervical and upper thoracic regions, conventional TENS, therapeutic ultrasound, conventional massage and Matrix Rhythm Therapy were applied.
Home-based exercise program and recommendations were also given to patients.
|
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.
|
EXPERIMENTAL: Control
Group II (15 subjects) received 10 sessions as 5 sessions a week.
Hot pack to cervical and upper thoracic regions, conventional TENS, therapeutic ultrasound and conventional massage were applied.
Home-based exercise program and recommendations were also given to patients.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Baseline
|
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
|
Muscle spasm
Time Frame: Baseline
|
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
|
Disability
Time Frame: Baseline
|
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
|
Emotional status
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 2 weeks
|
Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm
|
2 weeks
|
Muscle spasm
Time Frame: 2 weeks
|
Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm)
|
2 weeks
|
Disability
Time Frame: 2 weeks
|
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
|
Emotional status
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Emine ASLAN TELCİ, Professor, Pamukkale University
- Study Chair: Erhan ÖZFİDAN, Dr, Private Denizli Tekden Hospital
Publications and helpful links
General Publications
- 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. Epub 2013 Apr 26.
- 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, van der Windt DA; Exercise Therapy Group. Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. Aust J Physiother. 2005;51(2):71-85. doi: 10.1016/s0004-9514(05)70036-2.
- Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.01.2011/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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