Low Back PainNCT06140264
Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain
A study testing Acupuncture dry needle in people with Low Back Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupuncture dry needle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2022to 21 Feb 2023
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges from 20 to 45 years old.
- Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
- Presence of MTrPs at least in 4 muscles on any side.
- Patients had lower back myofascial pain syndrome for at least 3 months ago.
Who cannot join
- A history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Walid Kamal Abdelbasset
Al Kharj, Riyadh Region, 11942
About this study
Official title: Short Term Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain: A Randomized Controlled Clinical Trial
Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain.
Read the detailed description
Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain. Thirty patients their age ranged from 20 - 45 years participated in our study and divided randomly into two equal groups suffering from nonspecific low back pain. The first group (A) consist of 15 patients receiving acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, the second group (B) consist of 15 patients receiving only stretching and strengthening exercises for back muscles. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending and left side bending) were measured before and after treatment.
- Conditions
- Low Back Pain
- Being tested
- Acupuncture dry needle
- Keywords
- Acupuncture dry needle, Chronic mechanical low back pain
- 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.
Acupuncture dry needleOther
The muscles that have been treated iliocostalis lumborum, quadratus lumborum, gluteus medius and piriformis muscles. The patients received 2 sessions per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture dry needle | Active comparator | This group received acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, 2 sessions per week for 2 weeks. Receives: Other: Acupuncture dry needle |
| Stretching and strengthening exercises | No intervention | This group received only stretching and strengthening exercises for back muscles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain was assessed by Visual Analog Scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10 cm line with 0 in one end (no pain) and 10 (worst pain) on the other end. Patients were asked to place a mark along the line to denote their level of pain.
Measured: Four weeks
Secondary outcomes (2)
Functional disability
Functional disability of each patient was assessed by Oswestery disability questionnaire. It is valid and reliable tool. It is consists of 10 multiple choice questions for back pain, patient select one sentence out of six that best describe his pain, Higher scores indicated great pain. Scores (0-20%) minimal disability, Scores (20%- 40%) moderate, Scores (40% - 60%) severe, Scores (60%-80%) crippled, Scores (80% - 100%) patients are confined to bed.
Measured: Four weeks
Lumbar range of motion
Modified-modified Schober flexion technique was used based on the work of Williams et al. This method is reliable and valid in measuring range of motion of lumbar flexion. The investigator stood behind the standing patient to identify the posterior superior iliac spines with her or his thumbs, and then an ink mark was drawn along the midline of the lumbar spine horizontal to the posterior superior iliac spines. Another ink mark was made 15 cm above the original mark; the distance between superior and inferior skin marks was measured. Then the investigator instructed the patient to bend forward into full lumbar flexion and the new distance between superior and inferior skin marks was measured.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2022
- Primary completion11 Jan 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140264
- Sponsor's protocol ID
- RHPT/022/035
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Acupuncture Dry Needle in Treatment of Chronic Mechanical Low Back Pain: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06140264
- Acronym / sponsor ID
- RHPT/022/035
- Conditions
- Low Back Pain
- Keywords
- Acupuncture dry needle, Chronic mechanical low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 18 Nov 2023 (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.
Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain.
Detailed description
Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Chronic mechanical low back pain (CMLBP) is the most common problem of the working-age population in modern industrial society; it causes a substantial economic burden due to the wide use of medical services and absence from work. The purpose of this trial was to evaluate the short-term effect of acupuncture dry needle in treatment of chronic mechanical low back pain. Thirty patients their age ranged from 20 - 45 years participated in our study and divided randomly into two equal groups suffering from nonspecific low back pain. The first group (A) consist of 15 patients receiving acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, the second group (B) consist of 15 patients receiving only stretching and strengthening exercises for back muscles. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending and left side bending) were measured before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture dry needle | Active comparator | Other: Acupuncture dry needleThis group received acupuncture dry needle over trigger points of back muscles followed by stretching and strengthening exercises for back muscles, 2 sessions per week for 2 weeks. |
| Stretching and strengthening exercises | No intervention | –This group received only stretching and strengthening exercises for back muscles. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranges from 20 to 45 years old.
- Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
- Presence of MTrPs at least in 4 muscles on any side.
- Patients had lower back myofascial pain syndrome for at least 3 months ago.
Key exclusion criteria (1 listed)
- A history of previous back surgery, neurologic deficit, current lower extremity symptoms, cardiopulmonary disease with decreased activity tolerance, rheumatologic conditions, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease, patients receiving other treatment in the form of physical therapy or medication for the duration of the study that may interfere with the results of this study.
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 |
|---|---|---|
| Acupuncture dry needleThe muscles that have been treated iliocostalis lumborum, quadratus lumborum, gluteus medius and piriformis muscles. The patients received 2 sessions per week for 2 weeks. | Other | Acupuncture dry needle |
Primary outcome
Pain intensity
Time frame: Four weeks
Pain was assessed by Visual Analog Scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10 cm line with 0 in one end (no pain) and 10 (worst pain) on the other end. Patients were asked to place a mark along the line to denote their level of pain.
2 secondary outcomes
Functional disability
Time frame: Four weeks
Lumbar range of motion
Time frame: Four 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 15 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture dry needle in people with Low Back Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 1 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 15 Feb 2024. 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 Saudi Arabia. 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: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.