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Lumbar RadiculopathyNCT04852900

Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

A study testing Decompression with 30%, Decompression with 40% and Decompression with 50% in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Lumbar Radiculopathy
What is being tested?
Decompression with 30%, Decompression with 40% and Decompression with 50%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 sitePakistan
Study dates
14 Oct 2020to 10 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both Genders
  • Age between 30 to 50 years
  • Unilateral Radiculopathy
  • Limited SLR (Less than 60 degree)
  • Pain on Numeric Pain Rating Scale < 7
  • BMI ≤ 30

Who cannot join

  • Severe paraspinal Muscle Spasm
  • Acute prolapse intervertebral disc
  • Bilateral Positive SLR
  • Osteoporotic
  • H/O Spinal Fracture

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Max spine rehab centre, G8 markaz

    Islamabad, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Read the detailed description

Decompression therapy differs from traction-based therapy in that the traction applied to the spine in decompression therapy is typically alternated between lower and higher levels of tension for predetermined periods of time. In either therapy, spinal tension is maintained for the period's typically extending 30-minutes or longer. This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Being tested
Decompression with 30%, Decompression with 40%, Decompression with 50%
Keywords
Pain, Radiculopathy, Lumbar, Decompression
Medical subject headings
Radiculopathy, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decompression with 30%Other

    • Hot Pack for 10 mins Soft Tissue Mobilization
    • Muscle Strengthening
    • Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

  • Decompression with 40%Other

    • Hot Pack for 10 mins Soft Tissue Mobilization
    • Muscle Strengthening
    • Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks

  • Decompression with 50%Other

    • Hot Pack for 10 mins Soft Tissue Mobilization
    • Muscle Strengthening
    • Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks
Study groups in NCT04852900
Study groupRoleWhat they receive
Decompression with 30%ExperimentalDecompression with 30% and mobilization
Receives: Other: Decompression with 30%
Decompression with 40%ExperimentalDecompression with 40% and mobilization
Receives: Other: Decompression with 40%
Decompression with 50%ExperimentalDecompression with 50% and mobilization
Receives: Other: Decompression with 50%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni-dimensional measure of pain intensity in adults(21). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Measured: 6th week

  2. SLR through Inclinometer

    The Straight Leg Raise (SLR) test is a neurodynamic test. Neurodynamic tests check the mechanical movement of the neurological tissues as well as their sensitivity to mechanical stress or compression. These tests, along with relevant history and decreased range of motion, are considered by some to be the most important physical signs of disc herniation, regardless of the degree of disc injury. SLR is a neural tension test that can be used to rule in or out neural tissue involvement as a result of a space occupying lesion, often a lumbar disc herniation. It is one of the most common neurological tests of the lower limb

    Measured: 6th week

  3. Oswestry Disability Index

    Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Most effective for persistent severe disability while the Roland-Morris is better for mild to moderate disability. Questionnaire examines perceived level of disability in 10 everyday activities of daily living

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start14 Oct 2020
  3. Primary completion15 Jun 2021
  4. Study completion10 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852900
Sponsor's protocol ID
REC/00856 Iqra Hamid
Status last verified
Aug 2021
First submitted
20 Apr 2021
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alexander CE, Weisbrod LJ, Varacallo MA. Lumbosacral Radiculopathy(Archived). 2024 Feb 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430837/

    PubMed 28613587

  • Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.

    PubMed 31788391

  • Chen BL, Guo JB, Zhang HW, Zhang YJ, Zhu Y, Zhang J, Hu HY, Zheng YL, Wang XQ. Surgical versus non-operative treatment for lumbar disc herniation: a systematic review and meta-analysis. Clin Rehabil. 2018 Feb;32(2):146-160. doi: 10.1177/0269215517719952. Epub 2017 Jul 17.

    PubMed 28715939

  • Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Park KB, Shin BC, Lee MS, Ha IH. Long-Term Course of Alternative and Integrative Therapy for Lumbar Disc Herniation and Risk Factors for Surgery: A Prospective Observational 5-Year Follow-Up Study. Spine (Phila Pa 1976). 2016 Aug 15;41(16):E955-E963. doi: 10.1097/BRS.0000000000001494.

    PubMed 26882505

  • Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.

    PubMed 22543563

  • Abdurrahman G, Şener Ü, Karabacak H, Kağan Ü. Kadın ve erkek genç erişkinler arasında fiziksel aktivite ve yaşam kalitesi farklılıklarının araştırılması. Kocatepe Tıp Dergisi. 2011;12(3):145-50.

  • Demirel A, Yorubulut M, Ergun N. Regression of lumbar disc herniation by physiotherapy. Does non-surgical spinal decompression therapy make a difference? Double-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2017 Sep 22;30(5):1015-1022. doi: 10.3233/BMR-169581.

    PubMed 28505956

  • Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.

Questions about this trial

What is this clinical trial studying?

A study testing Decompression with 30%, Decompression with 40% and Decompression with 50% in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04852900, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.

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