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Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain.

Plain-language guide to NCT06099470: not phased randomized trial of hCG (human chorionic gonadotropin), chronic pain: fibromyalgia & crps, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06099470
Phase
not phased
Status
completed
Start
2023-06-01
Completion (planned or actual)
2023-09-01
Participants
72 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Chronic Non-specific Low Back Pain
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin) for chronic pain: fibromyalgia & crps.

The parameters the researchers want to study is pain, disability, fear of movement, and quality of life.

It had three arms (groups): Real-time synchronized telerehabilitation program (STP). (experimental), Pre-recording non-synchronized telerehabilitation program (NSTP) (experimental) and Home non-supervised control group (HCG) (other).

Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom.

Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.

Minimum intervention which is a PDF file containing the same exercises with no follow ups.

The registry classes the interventions as other.

More on the Plan

This study is a randomized control trial with two intervention groups and one control group with total sample size of 72: 1.

Real-time synchronized telerehabilitation program (STP).

Pre-recording non-synchronized telerehabilitation program (NSTP).

Home non-supervised control group (HCG).

Who Took Part

The registry lists 72 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Persisting low back pain for the past 3 months. VAS score of at least 4. Age between 18 and 65. Ability to perform exercises.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: history of spinal surgery; history of spinal injury; misalignment or specific condition in the lumbar region.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the chronic pain: fibromyalgia & crps participants stayed in one arm throughout.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-06-01 with completion listed for 2023-09-01.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Visual Analog Scale (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Roland Morris Disability Questionnaire, Oswestry Disability Index, Tampa Scale for Kinesiophobia and SF-12 Health Questionnaire.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 72 people with chronic pain: fibromyalgia & crps.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, Chronic pain: fibromyalgia & CRPS research.

Our Notes on the Compound

hCG (human chorionic gonadotropin): An LH analog that drives Leydig-cell testosterone production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.