search
Back to results

The Effect of Matrix Rhythm Therapy in Patients With Chronic Neck Pain

Primary Purpose

Chronic Pain, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Matrix Rhythm Therapy
Control
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Matrix Rhythm Therapy, Massage, Physical Therapy, Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sarayköy Vocational School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Matrix Rhythm Therapy

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Pain intensity
Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm
Muscle spasm
Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm)
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
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.

Full Information

First Posted
January 1, 2021
Last Updated
January 5, 2021
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT04696341
Brief Title
The Effect of Matrix Rhythm Therapy in Patients With Chronic Neck Pain
Official Title
The Effectiveness of a Novel Massage Method Matrix Rhythm Therapy in Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2011 (Actual)
Primary Completion Date
April 8, 2011 (Actual)
Study Completion Date
May 6, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Physical Disability
Keywords
Matrix Rhythm Therapy, Massage, Physical Therapy, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matrix Rhythm Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Matrix Rhythm Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Baseline
Title
Muscle spasm
Description
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.
Time Frame
Baseline
Title
Disability
Description
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
Time Frame
Baseline
Title
Emotional status
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm
Time Frame
2 weeks
Title
Muscle spasm
Description
Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm)
Time Frame
2 weeks
Title
Disability
Description
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
Time Frame
2 weeks
Title
Emotional status
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine ASLAN TELCİ, Professor
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erhan ÖZFİDAN, Dr
Organizational Affiliation
Private Denizli Tekden Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sarayköy Vocational School
City
Denizli
ZIP/Postal Code
20300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because there is no web site to share my data
Citations:
PubMed Identifier
23621388
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. Epub 2013 Apr 26.
Results Reference
result
PubMed Identifier
15924510
Citation
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.
Results Reference
result
PubMed Identifier
17369784
Citation
Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
Results Reference
result

Learn more about this trial

The Effect of Matrix Rhythm Therapy in Patients With Chronic Neck Pain

We'll reach out to this number within 24 hrs