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CompletedNCT05315115Updated Oct 26, 2024

Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.

An interventional study of Sham intervention and Chiropractic Care in Spinal Cord Injuries, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-26.

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

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults.

02

Conditions studied

  • Spinal Cord Injuries
03

In context

Spinal Cord Injuries

1,991 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's enrollment of 29 is above the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with both genders (Male and Female).
  • Age above 20 years.
  • Spinal Cord Injuries adults.

Exclusion criteria

Exclusion criteria

  • Spinal Cord Injury due to Traumatic Brain Injury.
  • Patients having cognitive impairments.
  • Patients having associated Neurological Pathologies.
  • Patients who are unable to follow the treatment plan.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Experimental group

    A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.

    Other: Chiropractic Care · Other: Physical therapy intervention

  • Sham comparator
    Control group

    The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.

    Other: Sham intervention · Other: Physical therapy intervention

Interventions

  • OtherSham intervention

    The participant's head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust.

  • OtherChiropractic Care

    A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.

  • OtherPhysical therapy intervention

    The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Spinal Cord Injuries children, where Conventional Therapy will be provided according to the respective needs of the individual patient.

06

What researchers measure

Primary outcomes

  1. Functional Independence Measure (FIM)

    The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured at baseline.

    Time frame: Baseline

  2. Functional Independence Measure (FIM)

    The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. This tool will be measured after 4 weeks.

    Time frame: 4 weeks

  3. ASIA scale

    The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured at baseline.

    Time frame: Baseline

  4. ASIA scale

    The American Spinal Injury Association (ASIA) impairment scale describes a person's functional impairment as a result of a Spinal Cord Injury. This scale indicates how much sensation a person feels after light touch and a pinprick at multiple points on the body and tests key motions on both sides of the body. This tool will be measured after 4 weeks.

    Time frame: 4 weeks

  5. Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)

    The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention.

    Time frame: Baseline

  6. Spine Dysfunction, Stress & Sensory-Motor Integration Questionnaire (SSSMQ)

    The SSSMQ is a newly developed tool to assess Spine Dysfunction Characteristics, logical and Psychological Stress Symptoms, and Multimodal and Sensorimotor Integration Dysfunction Symptoms. A baseline assessment of a participant will be done before the start of the intervention. This tool will be measured after 4 weeks.

    Time frame: 4 weeks

  7. 36-Item Short Form Survey (SF-36)

    The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. A baseline assessment of a participant will be done before the start of the intervention.

    Time frame: Baseline

  8. 36-Item Short Form Survey (SF-36)

    The SF-36 was originally designed as a generic health measure but has also been applied to specific disease populations. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to the high quality of life. This tool will be measured after 4 weeks.

    Time frame: 4 weeks

07

Study locations

1 site
  • National Institute of rehabilitation medicine.
    Islamabad, Federal 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05315115
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Apr 7, 2022
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022
Last update
Oct 26, 2024

Study contacts

IMRAN AMJAD, PhD
principal investigator · Riphah International University

Oversight

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

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