Back PainNCT06545578
Effect of Motor Control Exercise Combined With Laser Or TENS on Pain, Range of Motion, and Functional Disability on Obese Patients With Low Back Pain
A study testing low-level laser therapy and TENS in people with Back Pain and Obesity, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This randomized study aimed to assess the impact of MCE in conjunction with LLLT and MCE in conjunction with TENS on pain levels, ROM, and functional disability in obese patients with LBP. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Obesity, Motor Control Exercises
- What is being tested?
- low-level laser therapy and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2023to 30 Jul 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria were the following:
- patients aged 40 to 77 years
- non-athletic, have a BMI > 25
- complaining of LBP.
Who cannot join
- The exclusion criteria were the following:
- vertebral fractures
- surgical spinal fixation
- rheumatic disorders
- any underlying medical condition that may be causing back pain, including:
- malignancy
Show all 10Show fewer
- viscerogenic causes
- infection, systemic disease of the muscles and skeletal system,
- sensory dysfunction
- neuromuscular diseases like multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized study aimed to assess the impact of MCE in conjunction with LLLT and MCE in conjunction with TENS on pain levels, ROM, and functional disability in obese patients with LBP.
Read the detailed description
Sixty obese male and female patients with LBP participated in this study. After providing informed consent, they were randomly divided into two equal groups, with Group A receiving MCE combined with LLLT and Group B receiving MCE combined with TENS.
- Conditions
- Back Pain, Obesity, Motor Control Exercises, Laser Therapy
- Being tested
- low-level laser therapy, TENS, motor control exercises
- Medical subject headings
- Back Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapyOther
The Low-level laser (LLL) pain-relief instrument RG-300IB (code E22), manufactured in China, was utilized for low-level laser therapy (LLLT) in Group A . The therapy employed a wavelength of 830 nm (near infrared) and involved careful skin contact hygiene at specified positions, 2.5 and 3.5 cm laterally from the spinous process (L4, L5, or S1) and one distal level segment. The laser operated at a repetition rate of 5,000, with a power density of 300 mW/cm2 and a power output of 10 mW. Each point received 3 J of energy, resulting in a density of 3 J/cm2, with four points. The spot size was 1 cm, and each point received a 30-second treatment. The energy was administered three times per week for four weeks
TENSOther
TENS Intelect Advanced device (Chattanooga, Mouguerre, France). The parameters for TENS stimulation included a frequency range of 60-80 Hz, a pulse width of 50-80 ms, and an intensity of 10-30 mA. Before commencing therapy, patients were provided information regarding the therapeutic approach and any potential adverse effects. During the procedure, two channels (four electrodes) were employed, with one set placed on the right and one on the left paraspinal muscles at the level of L2-L4. Active electrodes from the other channels were affixed 1.5 cm laterally to the spine, while passive electrodes were positioned 3 cm away. TENS therapy was utilized for 30 minutes in Group B, and the intensity of the pain and discomfort was adjusted to the patient's tolerance level.
motor control exercisesOther
Training in coordinated trunk muscle action, including decreasing overactive superficial muscles and independent activation of deep muscles (such as transversus abdominis and multifidus). Exercises for the pelvic floor muscles, controlling respiration, and regulating the position and movement of the spine were added to these exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group (A): | Experimental | Group A received motor control exercises with low level laser therapy Receives: Other: low-level laser therapy; Other: motor control exercises |
| Group (B): | Experimental | Group B received motor control exercises with transcutaneous electrical nerve stimulation Receives: Other: TENS; Other: motor control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain was evaluated utilizing the visual analog scale (VAS)
It comprises a 10-centimeter-long horizontal line secured at both ends with anchors. The initial anchor signifies the absence of pain, whereas the final anchor represents the most terrible pain. The patient was instructed to indicate the point through the line that most accurately represented the intensity of discomfort. The measurement was obtained by tracing the distance from the zero extremities to the patient's mark
Measured: before treatment and 4 weeks after treatment
the functional disability, the Oswestry disability questionnaire version 2.0
Assessing functional disability in patients afflicted with LBP is accomplished with a valid and dependable instrument. There are six possible responses to each of the ten queries, which includes the daily functional disability. The patient chose the response that best described his impairment. Scores up to 50 are possible and are divided as follows: each question takes 5, the first statement takes 0, and the sixth statement takes 5 scores. The maximum score in this study was 45. All scores were subsequently tallied and converted to a percentage of the total score. A greater score is indicative of a severe disability. Scores between 0 and 20 represent minimal disability. Disability levels are classified as follows: scores between 40 and 60 indicate moderate disability; scores between 60 and 80 indicate disabled disability; and scores between 80 and 100 indicate bedridden patients
Measured: before treatment and 4 weeks after treatment
1- Assessment of lumbar flexion ROM
The researcher positioned himself behind the patient standing to use his thumbs to identify the two posterior superior iliac spines (PSIS). He then delineated these two spines with a line on the skin, with the first mark located at the midpoint of the line and the second mark positioned 15 cm above. Subsequently, the researcher directed the patient to flex forward to the greatest extent possible while remaining within the boundaries of pain
Measured: before treatment and 4 weeks after treatment
2- Assessment of lumbar extension ROM
Instructing the patient to bend backward to the best of his ability within the boundaries of pain, the investigator established a line on the skin and positioned himself behind the standing patient to distinguish between the two PSIS with his thumbs. The first mark was located at the midpoint of this line, and the second mark was positioned 15 cm above the first.
Measured: before treatment and 4 weeks after treatment
3- Assessment of lumbar side bending ROM
As the patient assumed an erect position with heels, buttocks, and shoulders against the wall and a lateral bend without elevating the opposing foot off the ground, the investigator determined the distance between the third fingertip and the floor.
Measured: before treatment and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start6 May 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ababa, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545578
- Sponsor's protocol ID
- P.T-ORTH-05/2023-511
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Control Exercise Combined With Laser Or TENS on Pain, Range of Motion, and Functional Disability on Obese Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT06545578
- Acronym / sponsor ID
- P.T-ORTH-05/2023-511
- Conditions
- Back Pain, Obesity, Motor Control Exercises, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 9 Aug 2024 (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.
This randomized study aimed to assess the impact of MCE in conjunction with LLLT and MCE in conjunction with TENS on pain levels, ROM, and functional disability in obese patients with LBP.
Detailed description
Sixty obese male and female patients with LBP participated in this study. After providing informed consent, they were randomly divided into two equal groups, with Group A receiving MCE combined with LLLT and Group B receiving MCE combined with TENS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): | Experimental | Other: low-level laser therapy, Other: motor control exercisesGroup A received motor control exercises with low level laser therapy |
| Group (B): | Experimental | Other: TENS, Other: motor control exercisesGroup B received motor control exercises with transcutaneous electrical nerve stimulation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged 40 to 77 years
- non-athletic, have a BMI > 25
- complaining of LBP.
Key exclusion criteria (10 listed)
- vertebral fractures
- surgical spinal fixation
- rheumatic disorders
- any underlying medical condition that may be causing back pain, including:
- malignancy
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 |
|---|---|---|
| low-level laser therapyThe Low-level laser (LLL) pain-relief instrument RG-300IB (code E22), manufactured in China, was utilized for low-level laser therapy (LLLT) in Group A . The therapy employed a wavelength of 830 nm (near infrared) and involved careful skin contact hygiene at specified positions, 2.5 and 3.5 cm laterally from the spinous process (L4, L5, or S1) and one distal level segment. The laser operated at a repetition rate of 5,000, with a power density of 300 mW/cm2 and a power output of 10 mW. Each point received 3 J of energy, resulting in a density of 3 J/cm2, with four points. The spot size was 1 cm, and each point received a 30-second treatment. The energy was administered three times per week for four weeks | Other | Group (A): |
| TENSTENS Intelect Advanced device (Chattanooga, Mouguerre, France). The parameters for TENS stimulation included a frequency range of 60-80 Hz, a pulse width of 50-80 ms, and an intensity of 10-30 mA. Before commencing therapy, patients were provided information regarding the therapeutic approach and any potential adverse effects. During the procedure, two channels (four electrodes) were employed, with one set placed on the right and one on the left paraspinal muscles at the level of L2-L4. Active electrodes from the other channels were affixed 1.5 cm laterally to the spine, while passive electrodes were positioned 3 cm away. TENS therapy was utilized for 30 minutes in Group B, and the intensity of the pain and discomfort was adjusted to the patient's tolerance level. | Other | Group (B): |
| motor control exercisesTraining in coordinated trunk muscle action, including decreasing overactive superficial muscles and independent activation of deep muscles (such as transversus abdominis and multifidus). Exercises for the pelvic floor muscles, controlling respiration, and regulating the position and movement of the spine were added to these exercises. | Other | Group (A):, Group (B): |
Primary outcome
The pain was evaluated utilizing the visual analog scale (VAS)
Time frame: before treatment and 4 weeks after treatment
It comprises a 10-centimeter-long horizontal line secured at both ends with anchors. The initial anchor signifies the absence of pain, whereas the final anchor represents the most terrible pain. The patient was instructed to indicate the point through the line that most accurately represented the intensity of discomfort. The measurement was obtained by tracing the distance from the zero extremities to the patient's mark
the functional disability, the Oswestry disability questionnaire version 2.0
Time frame: before treatment and 4 weeks after treatment
Assessing functional disability in patients afflicted with LBP is accomplished with a valid and dependable instrument. There are six possible responses to each of the ten queries, which includes the daily functional disability. The patient chose the response that best described his impairment. Scores up to 50 are possible and are divided as follows: each question takes 5, the first statement takes 0, and the sixth statement takes 5 scores. The maximum score in this study was 45. All scores were subsequently tallied and converted to a percentage of the total score. A greater score is indicative of a severe disability. Scores between 0 and 20 represent minimal disability. Disability levels are classified as follows: scores between 40 and 60 indicate moderate disability; scores between 60 and 80 indicate disabled disability; and scores between 80 and 100 indicate bedridden patients
1- Assessment of lumbar flexion ROM
Time frame: before treatment and 4 weeks after treatment
The researcher positioned himself behind the patient standing to use his thumbs to identify the two posterior superior iliac spines (PSIS). He then delineated these two spines with a line on the skin, with the first mark located at the midpoint of the line and the second mark positioned 15 cm above. Subsequently, the researcher directed the patient to flex forward to the greatest extent possible while remaining within the boundaries of pain
2- Assessment of lumbar extension ROM
Time frame: before treatment and 4 weeks after treatment
Instructing the patient to bend backward to the best of his ability within the boundaries of pain, the investigator established a line on the skin and positioned himself behind the standing patient to distinguish between the two PSIS with his thumbs. The first mark was located at the midpoint of this line, and the second mark was positioned 15 cm above the first.
3- Assessment of lumbar side bending ROM
Time frame: before treatment and 4 weeks after treatment
As the patient assumed an erect position with heels, buttocks, and shoulders against the wall and a lateral bend without elevating the opposing foot off the ground, the investigator determined the distance between the third fingertip and the floor.
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 Aug 2024.
- 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.
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 low-level laser therapy and TENS in people with Back Pain and Obesity, run by Ahram Canadian University at 1 site in Egypt.
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 10 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 Aug 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 Egypt. 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?
The pain was evaluated utilizing the visual analog scale (VAS) (time frame: before treatment and 4 weeks after treatment). The study lists 5 primary outcomes in all. 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 9 Aug 2024.