GOALS Intervention for Chronic Pain

1
Effectiveness
1
Safety
Family Health Centers of San Diego, San Diego, CA
Chronic Pain+4 More
GOALS Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Chronic Pain

Study Summary

This study is evaluating whether a cognitive behavioral physical therapy program can help people with chronic neck or low back pain.

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Eligible Conditions

  • Chronic Pain
  • Low Back Pain
  • Neck Pain
  • Back Pain
  • Chronic Lower Back Pain (CLBP)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether GOALS Intervention will improve 10 secondary outcomes and 28 other outcomes in patients with Chronic Pain. Measurement will happen over the course of Change from Baseline to Post-Intervention (1-week).

Baseline
Treatment Expectancy Measure
Baseline, Post-Intervention (1-week, 3-month)
PROMIS Short-Form Physical Function 4a
Baseline; Post Intervention (1-week, 3-month)
Fear Avoidance Beliefs Questionnaire (FABQ)
Baseline; Post-Intervention (1-week)
Medical Outcomes Study - Social Support Measure (MOS-SS)
Physical Activity (Actigraph)
Physical Activity and Sedentary Behavior (Actigraph)
Physical Activity and Sleep Measures (Actigraph)
Posture and Movement Measures (DorsaVi)
Sleep Duration (Actigraph)
Sleep Efficiency (Actigraph)
Sleep Onset (Actigraph)
Baseline; Post-Intervention (1-week, 3-month)
New General Self-Efficacy Scale (GSES)
PROMIS Short-Form Ability to Participate 4a
PROMIS Short-Form Anxiety 4a
PROMIS Short-Form Depression 4a
PROMIS Short-Form Sleep Disturbance
Pain Catastrophizing Scale (PCS)
Pain Self-Efficacy Questionnaire (PSEQ)
Rapid Assessment of Physical Activity (RAPA)
Rapid Assessment of Physical Activity (RAPA) Aerobic
Rapid Assessment of Physical Activity (RAPA) Strength and Flexibility
Self-Efficacy and Exercise Habits Survey (SEHS)
Change from Baseline to Post-Intervention (1-week)
30-s Sit-to-Stand
6-Meter Walk Test
Overhead Lift Task
Squat Lift Task
Change from Baseline to Post-Intervention (1-week, 3-month, 6-month)
Brief Pain Inventory (BPI) - Pain Intensity
Modified Oswestry Disability Index (ODI)
Neck Disability Index (NDI)
PEG-3
Patient Specific Functional Scale (PSFS)
Change from Baseline to Post-Intervention (3-month, 6-month)
Brief Pain Inventory (BPI) - Pain Interference
Once weekly during 8-week GOALS intervention
Adverse Event Checklist
Goal Attainment Scale
Post-Intervention (1-week)
Kim Alliance Scale (KAS)
Post-Intervention (1-week, 3-month, 6-month)
Global Impression of Change (GIC)
Global Rating of Satisfaction (GRS)
Post-Intervention (3-month, 6-month)
Post-Intervention Survey

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Usual Care Physical Therapy
GOALS Intervention

This trial requires 138 total participants across 2 different treatment groups

This trial involves 2 different treatments. GOALS Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

GOALS Intervention
Behavioral
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.
Usual Care Physical Therapy
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-intervention (1-week, 3-month, 6-month)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-intervention (1-week, 3-month, 6-month) for reporting.

Who is running the study

Principal Investigator
S. G.
Prof. Sara Gombatto, Associate Professor
San Diego State University

Closest Location

Family Health Centers of San Diego - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Referred to physical therapy by primary care physician
18-66 years old
You are Hispanic. show original
Diagnosis of chronic neck or low back pain
Must attend at least 1 physical therapy treatment session

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes chronic pain?

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A complex and incomplete picture of the underlying mechanisms and conditions resulting in chronic pain is emerging, and research may be addressing many aspects of chronic pain in different clinical conditions and patient groups.

Unverified Answer

What is chronic pain?

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Chronic pain is defined as pain that persists over 3 months. It can cause significant disability and economic hardship. Chronic pain affects between 3 and 4% of the United States population, is a significant contributor to healthcare utilization, and affects a significant portion of workplace productivity.\n

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What are common treatments for chronic pain?

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Chronic pain is commonly treated with nonpharmacological approaches. These include cognitive-behavioral therapy, relaxation training, biofeedback, exercise, and acupuncture. Nonsteroidal anti-inflammatories are commonly used to treat musculoskeletal pain. Medications are commonly used to treat pain associated with chronic inflammation. The use of prescription opioids is sometimes necessary for serious pain syndromes. There are many variations and combinations of these treatments.

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What are the signs of chronic pain?

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When discussing the causes of pain in the setting of primary care, many people do not notice that they have a chronic pain problem, let alone that it is a chronic pain problem. Results from a recent paper describes signs of chronic pain in many different areas and settings that patients may not often notice or discuss. These signs should be part of the discussion with patients, their families, and their prescribers. The signs are as follows: pain, tenderness, diminished enjoyment of life, and loss of work, and sleep. In the next section of this article, we consider how to evaluate these signs based on the NICE guidelines.

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How many people get chronic pain a year in the United States?

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Most adults (75%) reported getting chronic pain. It became more common with advancing age, and most reported having had it before. We should be aware of this and the impact it likely has on our society.

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Can chronic pain be cured?

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Although the vast majority of the chronically ill with chronic pain, and the very majority with chronic pain of all types, report relief of most symptoms within a mean of 4+ months of treatment with opioids, antidepressants, or NSAIDs, most experience little or no relief from these drugs, as well as opioids and antidepressants. A significant minority reports relief from opioids, antidepressants, and NSAIDs, but less frequently reports relief from either opioids, antidepressants, or NSAIDs, suggesting that no one type of chronic pain is consistently relievable with all treatments. Although chronic pain relief is often a desirable goal, such relief seems to be infrequently achieved when patients use the most popular treatments.

Unverified Answer

How does goals intervention work?

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Interventions that promote goals may be an effective strategy to implement in chronic pain rehabilitation and may be worthy of further study with regards to the extent to which they facilitate other goals set for rehabilitation in chronic pain.

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What does goals intervention usually treat?

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It is important to note that the present study does not allow us to draw any solid conclusions about the results because it was a single study with a sample size smaller than 60, and that participants were not randomly assigned to the goals-intervention and the usual care groups or to either of the two groups during follow-up. Our finding indicates that the participants who were allocated to the goals-intervention group experienced greater improvements in goals than participants who received the usual care.

Unverified Answer

How serious can chronic pain be?

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The seriousness of chronic pain is not yet understood by all professionals. Despite the fact that studies suggest that a large portion of chronic pain sufferers may be left untreated, only a small portion of primary care physicians have had formal training in pain management. Thus providers with a primary care background are especially in need of basic education about chronic pain. Further studies are needed to evaluate any impact of this formal training on patients' symptoms and outcomes and to assess the adequacy of chronic pain management in primary care.

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Who should consider clinical trials for chronic pain?

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The majority of participants who are eligible do not currently have a prescription for an opioid. Therefore, they should be recruited for RCTs investigating clinical treatments for chronic pain but be less concerned than current trials of obtaining detailed information on baseline characteristics.

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Have there been other clinical trials involving goals intervention?

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Goals intervention demonstrated short- and long-term benefits when added to traditional care in patients with chronic pain. Further large-scale, multicenter studies are urgently required to address the efficacy of goal-based interventions for chronic pain.

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Does chronic pain run in families?

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Although some of these symptoms may be associated with certain genetic factors, other factors such as the environment and social relationships appear to be more important.

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