Health TrialsbyHealthPanel

Rewiring Chronic Pain

ConditionsFull PRTPartial PRT (Non Somtic)Treatment as Usual
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorBen-Gurion University of the Negev

About this trial

This study examines the effectiveness of a brief psychological intervention for chronic pain treatment, as well as the psychological and neurophysiological mechanisms associated with changes in pain intensity.

Participants with chronic pain will be randomly assigned to one of three groups: two types of brief psychological interventions and a treatment-as-usual control group. Throughout the study, participants will attend a series of therapeutic sessions, complete questionnaires, undergo brain measurements (EEG and MRI), and participate in physiological monitoring using a smartwatch.

The study aims to investigate which cognitive and physiological changes occur during the intervention, and whether early markers can be identified that may predict improvement in pain following this type of treatment. In addition, differences between cognitive and somatic components of the intervention will be examined to better understand which elements contribute to clinical change, and to determine whether knowledge alone is sufficient or whether participants must undergo a bodily experience in order to produce changes in pain levels.

The goal of the study is to improve understanding of the mechanisms underlying chronic pain and responses to psychological treatments, and to contribute to the development of more personalized, effective treatments with minimal side effects in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-70 years

Chronic pain lasting over 3 months, including chronic pain conditions such as fibromyalgia and complex regional pain syndrome (CRPS)

Average pain intensity ≥4 on a 0-10 scale

Stable medication regimen for at least 4 weeks prior to treatment initiation

Disqualifiers

Current participation in other pain-related psychotherapy

Pregnancy

Substance abuse, including deviations from prescribed medication use

Change in medication or dosage in the 4 weeks preceding treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain Reprocessing Therapy (PRT)

    Behavioral

    In this full PRT, the participants will receive pain reprocessing therapy twice a week for four weeks (a total of 8 sessions). This treatment focuses on psychoeducation, cognitive restructuring and somatic elements. In the Partial PRT, participants will receive the same intervention, but without the somatic element.

  • TAU

    Other intervention

    Participants in this arm will receive treatment as usual.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Treatment as UsualActive comparator 1 intervention
Group B: Pain Reprocessing Therapy (PRT)Experimental treatment 1 intervention
Group C: Partial PRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average pain intensity in the first week post-treatment

Participants will be prompted twice daily via the Labfront app, connected to their wearable, to respond to the following single item from the Brief Pain Inventory (BPI): "Please rate your pain by circling the one number that tells how much pain you have right now," rated on a 0-10 numeric scale (0 = "No pain"; 10 = "Pain as bad as you can imagine"). Prompts will be delivered during 6 weeks, where the primary outcome will be the mean of all valid responses collected during the first week post-treatment.

Time frame
Twice a day for 6 weeks

Secondary outcomes

1

Pain severity: pre- to post-treatment score difference

Score of pain severity from Brief Pain Inventory- short form (average of items 3-6)

Time frame
4 weeks of treatment
2

Pain interference: pre- to post-treatment score difference

Score of pain interference from Brief Pain Inventory- short form (average of items 9A-9G)

Time frame
4 weeks of treatment
3

Pain levels (0-10) at up to 6 months follow-up

Participants will complete the Brief Pain Inventory (BPI) questionnaire, which includes the item: "Please rate your pain by circling the one number that best describes your pain on average (in the last week)," rated on a 0-10 numeric scale (0 = "No pain"; 10 = "Pain as bad as you can imagine"). The response to this item will serve as a secondary outcome measure of average pain intensity over the preceding week, assessed at up to 6-month follow-up.

Time frame
Up to 6 months post-treatment
4

Anxiety levels: pre- to post-treatment difference

Score of Generalized Anxiety Disorder questionnaire (GAD-7)

Time frame
4 weeks of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ben-Gurion University of the Negev

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: