Chronic PainNCT04696341
The Effect of Matrix Rhythm Therapy in Patients With Chronic Neck Pain
A study testing Matrix Rhythm Therapy in people with Chronic Pain and Physical Disability, run by Pamukkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Physical Disability
- What is being tested?
- Matrix Rhythm Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2011to 6 May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having neck pain for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Physical Disability
- Being tested
- Matrix Rhythm Therapy, Control
- Keywords
- Matrix Rhythm Therapy, Massage, Physical Therapy, Neck Pain
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix Rhythm TherapyProcedure or surgery
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.
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Matrix Rhythm Therapy | Experimental | 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. Receives: Procedure: Matrix Rhythm Therapy |
| Control | Experimental | 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. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (4)
Pain intensity
Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm
Measured: 2 weeks
Muscle spasm
Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm)
Measured: 2 weeks
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
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start25 Mar 2011
- Primary completion8 Apr 2011
- Study completion6 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nur OYMAK SOYSAL, Pamukkale University
- Investigators
- Emine ASLAN TELCİ, Professor, Study chair, Pamukkale UniversityErhan ÖZFİDAN, Dr, Study chair, Private Denizli Tekden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696341
- Sponsor's protocol ID
- 25.01.2011/02
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because there is no web site to share my data
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.
PubMed 23621388Smidt 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.
PubMed 15924510Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
PubMed 17369784
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Novel Massage Method Matrix Rhythm Therapy in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04696341
- Acronym / sponsor ID
- 25.01.2011/02
- Conditions
- Chronic Pain, Physical Disability
- Keywords
- Matrix Rhythm Therapy, Massage, Physical Therapy, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 25 Mar 2011 (actual)
- Primary completion
- 8 Apr 2011 (actual)
- Study completion
- 6 May 2011 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matrix Rhythm Therapy | Experimental | Procedure: Matrix Rhythm TherapyGroup 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. |
| Control | Experimental | Procedure: ControlGroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having neck pain for at least 3 months
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matrix Rhythm TherapyHot 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. | Procedure or surgery | Matrix Rhythm Therapy |
| ControlHot 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. | Procedure or surgery | Control |
Primary outcome
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.
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.
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
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.
4 secondary outcomes
Pain intensity
Time frame: 2 weeks
Muscle spasm
Time frame: 2 weeks
Disability
Time frame: 2 weeks
Emotional status
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Results publication: PubMed 23621388Taspinar 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 publication: PubMed 15924510Smidt 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 publication: PubMed 17369784Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.
- Individual participant dataSharing planned: No. Because there is no web site to share my data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine ASLAN TELCİ, Professor study chair
Pamukkale University
Erhan ÖZFİDAN, Dr study chair
Private Denizli Tekden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix Rhythm Therapy in people with Chronic Pain and Physical Disability, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696341, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.