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Recruiting NCT06987175

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

No phase Interventional Low Back Pain Range of Motion Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sadante neo therapy, Conventional exercises.
Who it may be relevant to
Registry conditions: Low Back Pain, Range of Motion, Pain. Basic parameters: 20 Weeks — 40 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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 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.

Primary outcome measures

  • McGill Pain Questionnaire: [Time frame: 4th week]
Secondary outcome measures (2)
  • Oswestry disability index: [Time frame: 4th week]
  • Rand 36-items helath survey [Time frame: 4th week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Arthritis and pain care clinic Lahore. — Lahore

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. PMID 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. PMID 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. PMID 21971895

Identifiers

NCT: NCT06987175 · REC/RCR&AHS/24/0134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗