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NCT Number: NCT06987175

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Range of Motion Signs and Symptoms

Age range

20 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis and pain care clinic Lahore.

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Ameena Amjad, Phd

CONTACT

Ayesha Arshad, MS OMPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oswestry disability index:

    Time frame: 4th week

    This questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life

  2. Rand 36-items helath survey

    Time frame: 4th week

    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

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad, Phd

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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