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

NCT06987175 | Recruiting

• 1 other identifier: REC/RCR&AHS/24/0134
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain; Range of Motion; Pain

Keywords

sedante neo therapy; non specific low back pain; quality of life

Outcome Measures

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.

  4th week

Secondary Outcomes (2)

• Oswestry disability index:

  4th week

• Rand 36-items helath survey

  4th week

Study Arms (2)

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.

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.

Other: sadante neo therapy

Interventions

sadante neo therapy OTHER

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.

Sadante neo therapy

Conventional exercises OTHER

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

conventional exercises

Eligibility Criteria

• Age: 20 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Arthritis and pain care clinic Lahore.

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 36152527 BACKGROUND

• 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.

  PMID: 23947760 BACKGROUND

• 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.

  PMID: 21971895 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ameena Amjad, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)