CClinicalTrials.gg
RecruitingNCT06987175Updated Jul 4, 2025

Effects of Sedante Neo Therapy on Pain, Range of Motion and Quality of Life in Patients With Non Specific Low Back Pain.

An interventional study of sadante neo therapy and Conventional exercises in Low Back Pain, Range of Motion and Pain, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 20 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Weeks to 40 Weeks
Sex
All
01

Study 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 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.

02

Conditions studied

  • Low Back Pain
  • Range of Motion
  • Pain

Keywords

  • sedante neo therapy
  • non specific low back pain
  • quality of life
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Weeks to 40 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    conventional exercises

    receive 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

  • Experimental
    Sadante neo therapy

    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.

    Other: sadante neo therapy

Interventions

  • Othersadante neo therapy

    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.

  • OtherConventional exercises

    receive conventional exercises only. Conventional exercises will be performed for 20 minutes, each exercise will be performed 20 times with 10 seconds hold.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4th week

Secondary outcomes

  1. 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

    Time frame: 4th week

  2. 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

    Time frame: 4th week

07

Study locations

1 of 1 sites recruiting
  • Arthritis and pain care clinic Lahore.
    Lahore, Punjab Province 54000, Pakistan
    • Ameena Amjad, Phd · Contact
    • Ayesha Arshad, MS OMPT · Principal investigator
    Recruiting
08

References and documents

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 36152527 ↗
  • Iglesias-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 23947760 ↗
  • Facci 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06987175
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 23, 2025
Start date
May 15, 2025
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jul 4, 2025

Study contacts

imran amjad, Phd
Contact
imran.amjad@riphah.edu.pk
03324390125
Ameena Amjad, Phd
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion