Low Back PainNCT05299216
Effect of Diaphragm Manual Therapy With Conventional Physical Therapy in Chronic Non-Specific Low Back Pain Patients
A study testing Manual Diaphragm Technique and Conventional Physical Therapy in people with Low Back Pain and Chronic Low-back Pain, run by University of Faisalabad at 2 sites in Pakistan.
Trial summary
A randomized single-blind clinical study will be performed. A sample size of 34 patients including only male gender, will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men only
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain
- What is being tested?
- Manual Diaphragm Technique and Conventional Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Apr 2022to 30 Aug 2022
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-55 years.
- Male gender
- Patients diagnosed as having non-specific chronic low back pain from the last 12 weeks minimum.
- Pain rating of at least 3 on Numerical Pain Rating Scale.
Who cannot join
- Previous history of spinal trauma, fracture or surgery.
- Patients with lumbar disc herniation and radicular low back pain.
- Patients having any spinal malignancy, psychological distress, infectious disorder or systemic disorder.
- Patients with tuberculosis of the spine.
- Patients with musculoskeletal injuries of the lower extremities.
- Patients who regularly consume anti-inflammatory or analgesic drugs.
- Previous history of manual treatment in the last month.
- Patients having contraindications for manual therapy.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Muhammad Hospital, Samnabad
Faisalabad, Punjab Province, 38000
Physio & Pain Care Clinic
Faisalabad, Punjab Province, 38000
About this study
Official title: Effect of Conventional Physical Therapy With or Without Diaphragm Manual Therapy in Patients With Chronic Non-Specific Low Back Pain
A randomized single-blind clinical study will be performed. A sample size of 34 patients including only male gender, will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment. Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25.
Read the detailed description
Over 80% of people experience Lower back pain in their lives, of which 23% suffer from chronic pain. Physiotherapists use multiple treatment options for treating non-specific chronic low back pain such as joint mobilization, therapeutic exercises, electrotherapeutic modalities and soft tissue release techniques.
The objective of the study is to determine the effect of conventional physical therapy with or without diaphragm manual therapy in patients with chronic non-specific low back pain.
A randomized, single-blind clinical study will be performed. A sample size of 34 patients comprising of only male gender will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment.
Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25. Mean ± Standard Deviation will be used to present Quantitative variables while Qualitative variables will be shown through frequency tables and percentages will be shown in the form of frequency tables and percentages. Summary of group measurements will be represented through Graphs. Normal distribution of data will be analyzed through skewness, kurtosis and Shapiro wilk test. If data is found normally distributed, then parametric tests will be applied, which will include an Independent sample t-test for measuring inter-group changes. Paired Sample t-test/Repeated measure ANOVA for measuring intra-group differences. If data is found non-normally distributed, then non-parametric tests will be applied, which will include Mann-Whitney U-Test for measuring inter-group changes and Wilcoxon Test/Friedman Test for measuring intra-group differences. P-value ≤ 0.05 will be taken as significant.
- Conditions
- Low Back Pain, Chronic Low-back Pain
- Being tested
- Manual Diaphragm Technique, Conventional Physical Therapy, Sham Diaphragm Manual Technique
- Keywords
- Low Back Pain, Manual Therapy, Conventional Physical Therapy
- 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.
Manual Diaphragm TechniqueOther
Treatment group will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Therapist will make physical contact to the underside of the 7th to 10th rib costal cartilages. During the inspiratory phase, the therapist will use both hands to gently pull the points of contact in the direction of the head. During exhalation, the therapist will maintain resistance. The procedure will be done in two sets of ten deep breaths, separated by a one-minute pause.
Conventional Physical TherapyOther
Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Subjects will undergo a thermal continuous ultrasound, conventional transcutaneous electrical nerve stimulation and a hot pack.
Stretching activities for the back, iliopsoas, and hamstring muscles, as well as abdominal muscle strengthening exercises, will be included in the workout.
Sham Diaphragm Manual TechniqueOther
The Control group will also receive a sham diaphragm release technique. The therapist and participant will have the same manual contacts, duration, and placement as the treatment group, but the therapist will simply use a light touch with the same anatomical landmarks and will not apply pressure.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week. Receives: Other: Manual Diaphragm Technique; Other: Conventional Physical Therapy |
| Group B | Active comparator | Group B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week. Receives: Other: Conventional Physical Therapy; Other: Sham Diaphragm Manual Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical Pain Rating Scale (Pain)
Numerical Pain Rating Scale will be used to measure back pain. Score of scale ranges from 0 (no pain) to 10 (worst possible pain).
Measured: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Change in Universal Goniometer (Lumbar Range of Motion)
Universal Goniometer will be used to measure Lumbar Range of Motion.
Measured: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Secondary outcomes (2)
Change in Oswestry Disability Index (Back Function Disability)
Oswestry Disability Index original English version (United States) and Urdu translated version (Pakistan) to measure back function disability. Score of this scale ranges from 0(no disability) to 50(completely disabled).
Measured: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Change in Short Form 12 Health Survey (Health Related Quality of Life)
Short Form 12 Health Survey Questionnaire original English version (United States) and Urdu translated version (Pakistan) will be used to assess health related quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Ammar Ahmad Sohail, University of Faisalabad
- Investigators
- Dr. Mariam Mehmood, MS-OMPT, Principal investigator, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299216
- Sponsor's protocol ID
- DRMAAS
- Status last verified
- May 2023
- First submitted
- 4 Mar 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
PubMed 26386894Ozkaraoglu DK, Tarakci D, Algun ZC. Comparison of two different electrotherapy methods in low back pain treatment. J Back Musculoskelet Rehabil. 2020;33(2):193-199. doi: 10.3233/BMR-181199.
PubMed 31594200Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
PubMed 25202177Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
PubMed 32000363Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3.
PubMed 23380824Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
PubMed 33781267Ibrahim AA, Akindele MO, Ganiyu SO, Kaka B, Abdullahi BB, Sulaiman SK, Fatoye F. The Hausa 12-item short-form health survey (SF-12): Translation, cross-cultural adaptation and validation in mixed urban and rural Nigerian populations with chronic low back pain. PLoS One. 2020 May 7;15(5):e0232223. doi: 10.1371/journal.pone.0232223. eCollection 2020.
PubMed 32379769Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
PubMed 29787734Comachio J, Magalhaes MO, Campos Carvalho E Silva APM, Marques AP. A cross-sectional study of associations between kinesiophobia, pain, disability, and quality of life in patients with chronic low back pain. Adv Rheumatol. 2018 Jun 22;58(1):8. doi: 10.1186/s42358-018-0011-2.
PubMed 30657061
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conventional Physical Therapy With or Without Diaphragm Manual Therapy in Patients With Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05299216
- Acronym / sponsor ID
- DRMAAS
- Conditions
- Low Back Pain, Chronic Low-back Pain
- Keywords
- Low Back Pain, Manual Therapy, Conventional Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 28 Mar 2022 (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.
A randomized single-blind clinical study will be performed. A sample size of 34 patients including only male gender, will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment. Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25.
Detailed description
Over 80% of people experience Lower back pain in their lives, of which 23% suffer from chronic pain. Physiotherapists use multiple treatment options for treating non-specific chronic low back pain such as joint mobilization, therapeutic exercises, electrotherapeutic modalities and soft tissue release techniques.
The objective of the study is to determine the effect of conventional physical therapy with or without diaphragm manual therapy in patients with chronic non-specific low back pain.
A randomized, single-blind clinical study will be performed. A sample size of 34 patients comprising of only male gender will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment.
Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25. Mean ± Standard Deviation will be used to present Quantitative variables while Qualitative variables will be shown through frequency tables and percentages will be shown in the form of frequency tables and percentages. Summary of group measurements will be represented through Graphs. Normal distribution of data will be analyzed through skewness, kurtosis and Shapiro wilk test. If data is found normally distributed, then parametric tests will be applied, which will include an Independent sample t-test for measuring inter-group changes. Paired Sample t-test/Repeated measure ANOVA for measuring intra-group differences. If data is found non-normally distributed, then non-parametric tests will be applied, which will include Mann-Whitney U-Test for measuring inter-group changes and Wilcoxon Test/Friedman Test for measuring intra-group differences. P-value ≤ 0.05 will be taken as significant.
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: Manual Diaphragm Technique, Other: Conventional Physical TherapyGroup A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week. |
| Group B | Active comparator | Other: Conventional Physical Therapy, Other: Sham Diaphragm Manual TechniqueGroup B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20-55 years.
- Male gender
- Patients diagnosed as having non-specific chronic low back pain from the last 12 weeks minimum.
- Pain rating of at least 3 on Numerical Pain Rating Scale.
Key exclusion criteria (8 listed)
- Previous history of spinal trauma, fracture or surgery.
- Patients with lumbar disc herniation and radicular low back pain.
- Patients having any spinal malignancy, psychological distress, infectious disorder or systemic disorder.
- Patients with tuberculosis of the spine.
- Patients with musculoskeletal injuries of the lower extremities.
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 |
|---|---|---|
| Manual Diaphragm TechniqueTreatment group will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Therapist will make physical contact to the underside of the 7th to 10th rib costal cartilages. During the inspiratory phase, the therapist will use both hands to gently pull the points of contact in the direction of the head. During exhalation, the therapist will maintain resistance. The procedure will be done in two sets of ten deep breaths, separated by a one-minute pause. | Other | Group A |
| Conventional Physical TherapyConventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Subjects will undergo a thermal continuous ultrasound, conventional transcutaneous electrical nerve stimulation and a hot pack. Stretching activities for the back, iliopsoas, and hamstring muscles, as well as abdominal muscle strengthening exercises, will be included in the workout. | Other | Group A, Group B |
| Sham Diaphragm Manual TechniqueThe Control group will also receive a sham diaphragm release technique. The therapist and participant will have the same manual contacts, duration, and placement as the treatment group, but the therapist will simply use a light touch with the same anatomical landmarks and will not apply pressure. | Other | Group B |
Primary outcome
Change in Numerical Pain Rating Scale (Pain)
Time frame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Numerical Pain Rating Scale will be used to measure back pain. Score of scale ranges from 0 (no pain) to 10 (worst possible pain).
Change in Universal Goniometer (Lumbar Range of Motion)
Time frame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Universal Goniometer will be used to measure Lumbar Range of Motion.
2 secondary outcomes
Change in Oswestry Disability Index (Back Function Disability)
Time frame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Change in Short Form 12 Health Survey (Health Related Quality of Life)
Time frame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
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 May 2023.
- Background: PubMed 26386894Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
- Background: PubMed 31594200Ozkaraoglu DK, Tarakci D, Algun ZC. Comparison of two different electrotherapy methods in low back pain treatment. J Back Musculoskelet Rehabil. 2020;33(2):193-199. doi: 10.3233/BMR-181199.
- Background: PubMed 25202177Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
- Background: PubMed 32000363Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
- Background: PubMed 23380824Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3.
- Background: PubMed 33781267Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
- Background: PubMed 32379769Ibrahim AA, Akindele MO, Ganiyu SO, Kaka B, Abdullahi BB, Sulaiman SK, Fatoye F. The Hausa 12-item short-form health survey (SF-12): Translation, cross-cultural adaptation and validation in mixed urban and rural Nigerian populations with chronic low back pain. PLoS One. 2020 May 7;15(5):e0232223. doi: 10.1371/journal.pone.0232223. eCollection 2020.
- Background: PubMed 29787734Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
- Background: PubMed 30657061Comachio J, Magalhaes MO, Campos Carvalho E Silva APM, Marques AP. A cross-sectional study of associations between kinesiophobia, pain, disability, and quality of life in patients with chronic low back pain. Adv Rheumatol. 2018 Jun 22;58(1):8. doi: 10.1186/s42358-018-0011-2.
- 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.
Dr. Mariam Mehmood, MS-OMPT principal investigator
University of Faisalabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Diaphragm Technique and Conventional Physical Therapy in people with Low Back Pain and Chronic Low-back Pain, run by University of Faisalabad at 2 sites in Pakistan.
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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Change in Numerical Pain Rating Scale (Pain) (time frame: Change from baseline at 2nd week and Change from 2nd week at 4th week.). The study lists 2 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 NCT05299216, which also lists 9 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 15 May 2023.