Low Back PainNCT06987175
Effects of Sedante Neo Therapy on Pain, Range of Motion and Quality of Life in Patients With Non Specific Low Back Pain.
A study testing sadante neo therapy and Conventional exercises in people with Low Back Pain and Range of Motion, run by Riphah International University at 1 site in Pakistan.
Trial summary
this study is to evaluate the effects of SADANTE neo therapy on pain, range of motion and quality of life in patients with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 40 weeks
- Conditions the study is for
- Low Back Pain, Range of Motion, Pain
- What is being tested?
- sadante neo therapy and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group of 20 yeras to 40 years.
- Both male and female included.
- Having non-specific low back pain.
- Having SF-MPQ score 1and 2 (1 means mild, 2 means moderate)
- Having ODI score 5 to 24
- Having SF-36 healty survey score below 50
- Having range of motion below normal.
Who cannot join
- Below 20 years and above 40 years patient are excluded
- Cervical, knee pain and other conditions excluded.
- Children are excluded
- Red flags ( tuberculosis, carcinoma heart disease etc) excluded
- -Open sores
- Psychiatric diseases such as depression, phobias
- Patient with history of surgery in lumber region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Arthritis and pain care clinic Lahore.
Lahore, Punjab Province, 54000
Ameena Amjad, Phd
Ayesha Arshad, MS OMPT
About this study
this study is to evaluate the effects of SADANTE neo therapy on pain, range of motion and quality of life in patients with non-specific low back pain.
Read the detailed description
This study is to evaluate SADANTE neo therapy on pain, range of motion and quality of life in patients with low back pain. This study will identify the effects that will help the physiotherapists in making the treatment plan for low back pain. This can be an alternative non pharmacological therapy to improve the quality of pain management with maximum benefits and minimal side effects.
- Conditions
- Low Back Pain, Range of Motion, Pain
- Being tested
- sadante neo therapy, Conventional exercises
- Keywords
- sedante neo therapy, non specific low back pain, quality of life
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sadante neo therapyOther
SAN machine having 3 tube cords on both sides. Each tube cord contains 2 pairs of flat suction cups. We will use 4 pair of flat suction cups in this study. We will place 2 pair on left and two on right para spinal muscles of lumber in prone lying. Due to its automatic suctioning capability, these cups can easily stick to skin. After placing the cups on lumber each patient of group A will receive its stimulation for about 10 minutes every day for about 4 weeks along with conventional exercises.
Conventional exercisesOther
receive conventional exercises only. Conventional exercises will be performed for 20 minutes, each exercise will be performed 20 times with 10 seconds hold.
| Study group | Role | What they receive |
|---|---|---|
| conventional exercises | Experimental | receive conventional exercises only. Conventional exercises will be performed for 20 minutes, each exercise will be performed 20 times with 10 seconds hold. Receives: Other: Conventional exercises |
| Sadante neo therapy | Experimental | SAN machine having 3 tube cords on both sides. Each tube cord contains 2 pairs of flat suction cups. We will use 4 pair of flat suction cups in this study. We will place 2 pair on left and two on right para spinal muscles of lumber in prone lying. Due to its automatic suctioning capability, these cups can easily stick to skin. After placing the cups on lumber each patient of group A will receive its stimulation for about 10 minutes every day for about 4 weeks along with conventional exercises. Receives: Other: sadante neo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire:
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.
Measured: 4th week
Secondary outcomes (2)
Oswestry disability index:
This questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
Measured: 4th week
Rand 36-items helath survey
The rand 36-items survey is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start15 May 2025
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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 Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameena Amjad, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987175
- Sponsor's protocol ID
- REC/RCR&AHS/24/0134
- Status last verified
- Jul 2025
- First submitted
- 15 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Comparison of dry needling and self-stretching in muscle extensibility, pain, stiffness, and physical function in hip osteoarthritis: A randomized controlled trial. Complement Ther Clin Pract. 2022 Nov;49:101667. doi: 10.1016/j.ctcp.2022.101667. Epub 2022 Sep 11.
PubMed 36152527Iglesias-Gonzalez JJ, Munoz-Garcia MT, Rodrigues-de-Souza DP, Alburquerque-Sendin F, Fernandez-de-Las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain. Pain Med. 2013 Dec;14(12):1964-70. doi: 10.1111/pme.12224. Epub 2013 Aug 15.
PubMed 23947760Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.
PubMed 21971895
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sedante Neo Therapy on Pain, Range of Motion and Quality of Life in Patients With Non Specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT06987175
- Acronym / sponsor ID
- REC/RCR&AHS/24/0134
- Conditions
- Low Back Pain, Range of Motion, Pain
- Keywords
- sedante neo therapy, non specific low back pain, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 May 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.
this study is to evaluate the effects of SADANTE neo therapy on pain, range of motion and quality of life in patients with non-specific low back pain.
Detailed description
This study is to evaluate SADANTE neo therapy on pain, range of motion and quality of life in patients with low back pain. This study will identify the effects that will help the physiotherapists in making the treatment plan for low back pain. This can be an alternative non pharmacological therapy to improve the quality of pain management with maximum benefits and minimal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional exercises | Experimental | Other: Conventional exercisesreceive conventional exercises only. Conventional exercises will be performed for 20 minutes, each exercise will be performed 20 times with 10 seconds hold. |
| Sadante neo therapy | Experimental | Other: sadante neo therapySAN machine having 3 tube cords on both sides. Each tube cord contains 2 pairs of flat suction cups. We will use 4 pair of flat suction cups in this study. We will place 2 pair on left and two on right para spinal muscles of lumber in prone lying. Due to its automatic suctioning capability, these cups can easily stick to skin. After placing the cups on lumber each patient of group A will receive its stimulation for about 10 minutes every day for about 4 weeks along with conventional exercises. |
Who may qualify
- Ages
- 20 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age group of 20 yeras to 40 years.
Key exclusion criteria (7 listed)
- Below 20 years and above 40 years patient are excluded
- Cervical, knee pain and other conditions excluded.
- Children are excluded
- Red flags ( tuberculosis, carcinoma heart disease etc) excluded
- -Open sores
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 |
|---|---|---|
| sadante neo therapySAN machine having 3 tube cords on both sides. Each tube cord contains 2 pairs of flat suction cups. We will use 4 pair of flat suction cups in this study. We will place 2 pair on left and two on right para spinal muscles of lumber in prone lying. Due to its automatic suctioning capability, these cups can easily stick to skin. After placing the cups on lumber each patient of group A will receive its stimulation for about 10 minutes every day for about 4 weeks along with conventional exercises. | Other | Sadante neo therapy |
| Conventional exercisesreceive conventional exercises only. Conventional exercises will be performed for 20 minutes, each exercise will be performed 20 times with 10 seconds hold. | Other | conventional exercises |
Primary outcome
McGill Pain Questionnaire:
Time frame: 4th week
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.
2 secondary outcomes
Oswestry disability index:
Time frame: 4th week
Rand 36-items helath survey
Time frame: 4th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 36152527Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Comparison of dry needling and self-stretching in muscle extensibility, pain, stiffness, and physical function in hip osteoarthritis: A randomized controlled trial. Complement Ther Clin Pract. 2022 Nov;49:101667. doi: 10.1016/j.ctcp.2022.101667. Epub 2022 Sep 11.
- Background: PubMed 23947760Iglesias-Gonzalez JJ, Munoz-Garcia MT, Rodrigues-de-Souza DP, Alburquerque-Sendin F, Fernandez-de-Las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain. Pain Med. 2013 Dec;14(12):1964-70. doi: 10.1111/pme.12224. Epub 2013 Aug 15.
- Background: PubMed 21971895Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Ameena Amjad, Phd principal investigator
Riphah International 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 sadante neo therapy and Conventional exercises in people with Low Back Pain and Range of Motion, run by Riphah International University at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Questionnaire: (time frame: 4th week). 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 NCT06987175, 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 4 Jul 2025.