What side effects are associated with this type of intervention?

Cognitive Behavioral Physical Therapy (CBPT) for pain management, such as the one studied in the GOALS trial, generally has minimal side effects. Common side effects may include temporary increases in pain or discomfort as patients engage in physical activities and exercises. Psychological interventions like CBPT can sometimes lead to emotional distress as patients confront and work through pain-related fears and anxieties. However, these side effects are typically mild and transient, and the overall risk profile is considered low compared to pharmacological treatments.

What prior FDA approvals exist?

The FDA has not specifically approved cognitive behavioral physical therapy (CBPT) for the treatment of neck pain. However, non-pharmacologic treatments such as physical therapy, exercise therapy, and cognitive-behavioral therapy (CBT) are widely recognized and recommended in clinical guidelines for managing chronic pain, including neck pain. These approaches focus on improving physical function and addressing the psychological aspects of chronic pain, similar to the GOALS trial's methodology. While specific FDA approvals for these therapies may not exist, their efficacy is supported by substantial clinical evidence.

What other types of research exist?

Promising alternatives to GOALS for neck pain management in 2024 include: 1) Multidisciplinary bio-psycho-social rehabilitation programs, which address physical, psychological, and social factors of pain. 2) Telehealth-based pain management programs that offer remote cognitive behavioral therapy and physical therapy. 3) Mindfulness-based stress reduction (MBSR) programs, which have shown effectiveness in reducing chronic pain. 4) Progressive muscle relaxation and guided imagery, which can help reduce pain and improve psychological outcomes. 5) Exercise therapy programs tailored to individual needs, focusing on movement control and graded activity.

← Back to Search

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Back and Neck Pain (GOALS Trial)

N/A

Waitlist Available

Led By Sara Gombatto, PT, Ph.D

Research Sponsored by San Diego State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-66 years old

Be older than 18 years old

Must not have

Tumor, infection, or other major medical problem affecting the neck or low back

Health problems that severely affect ability to move, walk one block, or participate in exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention (1-week, 3-month, 6-month)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the GOALS program, which combines various sessions to help Hispanic/Latino people with long-term neck or back pain. The program uses mental and physical exercises to manage pain. It aims to improve daily functioning by changing how patients think about and respond to their pain.

Who is the study for?

This trial is for Hispanic individuals aged 18-66 with chronic neck or low back pain, referred to physical therapy by a doctor. They must attend at least one session and cannot have major medical issues affecting the spine, severe mobility problems, be in litigation for pain, starting new psychotherapy for pain during the study, pregnant/lactating, or living with another participant.

What is being tested?

The GOALS program—a culturally adapted cognitive behavioral tele-rehabilitation—is being tested against usual care physical therapy. It includes two in-person sessions and six weekly phone calls over eight weeks. The main goal is to see if GOALS reduces pain-related disability more effectively than standard treatment.

What are the potential side effects?

Since this trial involves non-drug interventions like cognitive behavioral therapy and physical exercises provided via tele-rehabilitation or usual care physical therapy, typical medication side effects are not expected. However, participants may experience discomfort from engaging in new activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 66 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a major issue with my neck or low back, such as a tumor or infection.

Select...

I have severe health issues that limit my mobility and exercise ability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (1-week, 3-month, 6-month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (1-week, 3-month, 6-month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (1-week, 3-month, 6-month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

30-s Sit-to-Stand

6-Meter Walk Test

Brief Pain Inventory (BPI) - Pain Intensity

+5 more

Other study objectives

Adverse Event Checklist

Fear Avoidance Beliefs Questionnaire (FABQ)

Global Impression of Change (GIC)

+23 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GOALS InterventionExperimental Treatment1 Intervention

The experimental arm is an 8-week cognitive-behavioral based physical therapy (PT) intervention for chronic spine pain. The manualized intervention utilizes a hybrid tele-rehabilitation delivery model. GOALS comprises an initial in-person evaluation (60 min) by a research physical therapist, followed by 6 remote treatment sessions (30-45 min each) conducted by the same physical therapist once a week by telephone. A second in-person evaluation is conducted at the midpoint of the GOALS intervention to assess progress and advance the participant's home exercise program.

Group II: Usual Care Physical TherapyActive Control1 Intervention

The control arm is Usual Care physical therapy (PT) at a local Federally Qualified Health Center (FQHC), which offers PT services at 4 outpatient clinics across San Diego county. Participants in the Usual Care group attend an initial PT evaluation at a FQHC Physical Rehabilitation Clinic. The frequency and type of PT intervention are then determined by the treating physical therapist in accordance with standard clinical practice at the FQHC.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for neck pain include physical therapy, cognitive-behavioral therapy (CBT), and multimodal approaches combining both. Physical therapy works by improving movement, strength, and flexibility, which helps reduce pain and prevent further injury. CBT addresses the psychological aspects of pain, helping patients change negative thought patterns and behaviors that can exacerbate pain. Combining these approaches, as in Cognitive Behavioral Physical Therapy (CBPT), targets both the physical and psychological contributors to pain, leading to more comprehensive and effective pain management. Understanding these mechanisms is crucial for neck pain patients as it empowers them to engage actively in their treatment, improving outcomes and quality of life.

Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.