Low Back PainNCT06840795
Effect of Vibration Massager Therapy on Non-Specific Low Back Pain
A study testing conventional physiotherapy and State the device (Theragun PRO Plus) in people with Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- conventional physiotherapy and State the device (Theragun PRO Plus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 Feb 2026
- 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 back pain for the last 3 months VAS ≥ 4
- Between 18-65 years of age.
- Volunteers for the study.
- Not having undergone surgical intervention in the last 6 months
Who cannot join
- Structural spinal pathology or deformity.
- Recent spinal surgery.
- Chronic bone disease.
- Neurological or orthopedic disorders that could interfere with the assessments or treatment program.
- Use of hypnotic medication.
- Psychological or cognitive conditions that could prevent informed participation or completion of the assessments.
- Inability to cooperate with the study procedures.
- -The diagnosis of CNLBP and the absence of suspected serious spinal pathology were determined based on: (Medical history ,Clinical examination ,Available medical records)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Volt Therapy Health Medical and Consulting Ltd.
Istanbul
About this study
Official title: Effect of Vibration Massager Therapy on Non-Specific Low Back Pain: A Randomized Controlled Trial
The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain.
Read the detailed description
This study will be conducted using a randomized controlled design. Volunteers between the ages of 18-65 with non-specific low back pain will be included in the study. Inclusion criteria are that participants do not have structural pathologies and agree to participate in the study voluntarily. Exclusion criteria include spinal deformities and exercise intolerance. Participants will be randomly divided into two groups. Individuals in the first group will receive vibratory massage therapy, while the second group will be evaluated with standard treatment methods as a control. Both groups will receive treatment 3 times a week for 8 weeks. Participants' quality of life, pain levels, range of motion, and muscle activity will be evaluated before and after treatment. Data will be collected using tools such as SF-36, Oswestry Low Back Pain Index, and VAS (Visual Analog Scale).
- Conditions
- Low Back Pain
- Being tested
- conventional physiotherapy, State the device (Theragun PRO Plus)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
Conventional physiotherapy methods will be applied. Pain relief, electrotherapy, hot applications, ultrasound etc.
State the device (Theragun PRO Plus)Other
30-40 Hz, 10 min per session, and the treated regions; for CPT, hot pack 20 min + TENS 20 min + ultrasound ~8 min + supervised exercise. Must match the manuscript exactly.
| Study group | Role | What they receive |
|---|---|---|
| CPT alone | Active comparator | conventional physiotherapy Receives: Other: conventional physiotherapy |
| PVT + CPT | Experimental | vibration massage therapy in addition to conventional physiotherapy Receives: Other: conventional physiotherapy; Other: State the device (Theragun PRO Plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Pittsburgh Sleep Quality Index
The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month. There are seven components in Pittsburg Sleep Quality Index. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality.
Measured: Baseline and 8 weeks
Visual Analog Scale
1=no pain, 10=worst pain
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2025
- Primary completion10 May 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Ainaz Vahedi, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840795
- Sponsor's protocol ID
- Uskudar20
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lupowitz L. Vibration Therapy - A Clinical Commentary. Int J Sports Phys Ther. 2022 Aug 1;17(6):984-987. doi: 10.26603/001c.36964. eCollection 2022. No abstract available.
PubMed 36237646Li Q, Liu P, Wang Z, Li X. Vibration therapy to improve pain and function in patients with chronic low back pain: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Sep 26;18(1):727. doi: 10.1186/s13018-023-04217-2.
PubMed 37752526Leabeater AJ, Clarke AC, James L, Huynh M, Driller M. Under the Gun: Percussive Massage Therapy and Physical and Perceptual Recovery in Active Adults. J Athl Train. 2024 Mar 1;59(3):310-316. doi: 10.4085/1062-6050-0041.23.
PubMed 37248364Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
PubMed 33239942
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibration Massager Therapy on Non-Specific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06840795
- Acronym / sponsor ID
- Uskudar20
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 21 Feb 2025 (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.
The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain.
Detailed description
This study will be conducted using a randomized controlled design. Volunteers between the ages of 18-65 with non-specific low back pain will be included in the study. Inclusion criteria are that participants do not have structural pathologies and agree to participate in the study voluntarily. Exclusion criteria include spinal deformities and exercise intolerance. Participants will be randomly divided into two groups. Individuals in the first group will receive vibratory massage therapy, while the second group will be evaluated with standard treatment methods as a control. Both groups will receive treatment 3 times a week for 8 weeks. Participants' quality of life, pain levels, range of motion, and muscle activity will be evaluated before and after treatment. Data will be collected using tools such as SF-36, Oswestry Low Back Pain Index, and VAS (Visual Analog Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPT alone | Active comparator | Other: conventional physiotherapyconventional physiotherapy |
| PVT + CPT | Experimental | Other: conventional physiotherapy, Other: State the device (Theragun PRO Plus)vibration massage therapy in addition to conventional physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having back pain for the last 3 months VAS ≥ 4
- Between 18-65 years of age.
- Volunteers for the study.
- Not having undergone surgical intervention in the last 6 months
Key exclusion criteria (8 listed)
- Structural spinal pathology or deformity.
- Recent spinal surgery.
- Chronic bone disease.
- Neurological or orthopedic disorders that could interfere with the assessments or treatment program.
- Use of hypnotic medication.
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 |
|---|---|---|
| conventional physiotherapyConventional physiotherapy methods will be applied. Pain relief, electrotherapy, hot applications, ultrasound etc. | Other | CPT alone, PVT + CPT |
| State the device (Theragun PRO Plus)30-40 Hz, 10 min per session, and the treated regions; for CPT, hot pack 20 min + TENS 20 min + ultrasound ~8 min + supervised exercise. Must match the manuscript exactly. | Other | PVT + CPT |
Primary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: Baseline and 8 weeks
It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.
2 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Baseline and 8 weeks
Visual Analog Scale
Time frame: Baseline and 8 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 9 Sep 2026.
- Background: PubMed 36237646Lupowitz L. Vibration Therapy - A Clinical Commentary. Int J Sports Phys Ther. 2022 Aug 1;17(6):984-987. doi: 10.26603/001c.36964. eCollection 2022. No abstract available.
- Background: PubMed 37752526Li Q, Liu P, Wang Z, Li X. Vibration therapy to improve pain and function in patients with chronic low back pain: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Sep 26;18(1):727. doi: 10.1186/s13018-023-04217-2.
- Background: PubMed 37248364Leabeater AJ, Clarke AC, James L, Huynh M, Driller M. Under the Gun: Percussive Massage Therapy and Physical and Perceptual Recovery in Active Adults. J Athl Train. 2024 Mar 1;59(3):310-316. doi: 10.4085/1062-6050-0041.23.
- Background: PubMed 33239942Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
- Individual participant dataSharing planned: No
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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.
Ainaz Vahedi study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physiotherapy and State the device (Theragun PRO Plus) in people with Low Back Pain, run by Uskudar 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 4 inclusion and 8 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 9 Sep 2026. 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?
Oswestry Low Back Pain Disability Questionnaire (time frame: Baseline and 8 weeks). 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 NCT06840795, which also lists 4 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 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.