Clinical trial NCT06987175: Effects of Sedante Neo Therapy on Pain, Range of Motion and Quality of Life in Patients With Non Specific Low Back Pain.
Official title: Effects of Sedante Neo Therapy on Pain, Range of Motion and Quality of Life in Patients With Non Specific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Range of Motion
Pain
Keywords: sedante neo therapy
non specific low back pain
quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: McGill Pain Questionnaire:
timeFrame: 4th week
Secondary outcomes:
measure: Oswestry disability index:
timeFrame: 4th week
measure: Rand 36-items helath survey
timeFrame: 4th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Arthritis and pain care clinic Lahore.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ameena Amjad, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.