Non-Medication Pain Management Strategies for Chronic Pain
(OPTIONS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must not be taking: Opioids
Disqualifiers: Psychiatric hospitalization, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore the Veterans' values and goals and how different non-medication approaches may fit into these values and goals.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it focuses on non-medication strategies, so you might be able to continue your current meds while participating.
What data supports the effectiveness of non-medication treatments for chronic pain?
Non-medication treatments like physical therapy, massage, and acupuncture can help reduce pain and improve quality of life, although the evidence is not very strong and results can vary. These treatments are often appreciated by patients and can be tailored to individual needs to enhance well-being.
12345Are non-medication pain management strategies safe for humans?
Non-medication pain management strategies, such as acupuncture, massage therapy, and music therapy, are generally considered safe, noninvasive, and free of serious side effects. They can be used alongside standard treatments to help reduce pain and improve quality of life.
56789How is this treatment different from other treatments for chronic pain?
This treatment is unique because it focuses on non-medication strategies like physical therapy, massage, and acupuncture, which aim to improve well-being and functionality without relying on drugs. These methods are tailored to individual needs and are appreciated by patients for their holistic approach to managing chronic pain.
345710Eligibility Criteria
This trial is for Veterans with chronic musculoskeletal pain in the low back, neck, or limbs lasting at least 3 months. Participants should be open to non-medication treatments and have moderate pain affecting their life. They must not have severe cognitive issues, active suicidal thoughts, long-term opioid use, recent psychiatric hospitalization, or serious medical conditions like advanced heart failure.Inclusion Criteria
I have had pain in my back, neck, or limbs for at least 3 months.
I experience moderate pain that affects my daily activities.
I have a doctor's appointment scheduled within the next three months.
+1 more
Exclusion Criteria
A psychiatric hospitalization in the past 6 months
Eligibility screener reveals active suicidal ideation
Eligibility screener reveals cognitive impairment, defined by a score of >3 on MMSE cognitive screen
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a series of four coaching sessions focused on nonpharmacological pain management strategies
9 months
4 coaching sessions
Follow-up
Participants are monitored for changes in patient activation, quality of life, depression, pain interference, pain catastrophizing, use of nonpharmacological approaches, anxiety, and decisional conflict
6 months
Participant Groups
The study explores nonpharmacological strategies for managing chronic pain among Veterans. It involves working with a coach to align various non-medication approaches with the participants' values and goals in relation to their chronic pain management.
2Treatment groups
Experimental Treatment
Active Control
Group I: OPTIONS Intervention CoachingExperimental Treatment1 Intervention
Intervention participants will participate in a series of four coaching sessions focused on helping patients clarify their values and treatment goals, aligning these values and goals and their lifestyle with nonpharmacological treatment options, working on overcoming barriers to use and adherence of nonpharmacological treatment options (using motivational interviewing), and preparing patients to discuss these options with their primary care providers. A decision aid will be used during these coaching sessions.
Group II: OPTIONS Waitlist ControlActive Control1 Intervention
Participants randomized into waitlist control group will receive the intervention decision aid after completing the last survey at 9 months. Participants will also be offered the opportunity to have a brief 20-minute session with a member of the OPTIONS study staff to help walk them through this decision aid.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, IN
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Nonpharmacologic treatment of pain. [2022]Nonpharmacologic interventions for pain treatment are important complementary therapies but are not substitutes for pharmacologic management of pain. Use of nonpharmacologic pain treatments in critical care settings is helpful to decrease pain, but the challenge remains for nurses to have the knowledge, time, and skill to use these interventions in a busy daily practice with severely ill patients. Although numerous studies testing the effectiveness of nonpharmacologic interventions for pain management are available, the varying methods and interventions used in these studies make it difficult to draw conclusions. Further research on the use of these interventions for pain reduction is necessary to determine the most effective treatments and the conditions under which they should be used.
Nonpharmacologic interventions for pain management. [2018]Managing pain is a complex and inexact science. Acute and chronic pain physically and psychologically affects and disables an overwhelming number of people. Nonpharmacologic interventions for pain management have been reviewed. These methods can be used independently or in combination with other nonpharmacologic or pharmacologic methods of pain control. The goals of nonpharmacologic interventions for pain management include the reduction of pain, minimal adverse effects, and allowing patients to become active participants in their own care. Nurses are called on many times to comfort patients in pain. It is through their expertise and intervention that the goals of pain management succeed.
Opioid crisis renews interest in osteopathic manipulation. [2019]Toolbox of solutions: Chronic Pain management begins with counseling patients on achieving realistic pain relief goals. Engage patients in the management and treatment of their pain. Be open to multidisciplinary approaches. Goals should focus on reducing pain severity, improving functionality and gaining a better quality of life--not the immediate elimination of all pain.
[Nonpharmacological pain therapy for chronic pain]. [2019]The treatment of chronic pain should be a multimodal combination of pharmacological and nonpharmacological components. This article describes some of the nonpharmacological treatment options and their evidence (e.g. physical therapy, massage, manual therapy, electrotherapy, acupuncture and music therapy). The evidence for an empirically detected effectiveness of all these forms of therapy is not very high and often inconsistent. Nevertheless, this does not mean that these forms of treatment should not be used but that they should be selected on an individual basis to improve the well-being of patients by being adjusted to their needs.
[The non-pharmacological management of chronic pain]. [2017]Pain management is not limited to the putting in place of pharmacological, surgical, physiotherapy or psychological strategies. Non-pharmacological therapies can also be proposed, notably in relation to chronic pain. Appreciated by patients and developed by caregivers, they require appropriate regulatory guidelines and specific training in order for them to be implemented safely.
The 2021 NICE guidelines for assessment and management of chronic pain: A cross-sectional study mapping against a sample of 1,000* in the community. [2022]To characterise the prevailing pharmacological and non-pharmacological pain management strategies among adults with chronic pain, comparing these against the newly published NICE guidelines NG-193, and examine these pre-NG-193 pain management strategies in relation to pain severity, pain interference, sleep quality and mental health outcomes.
Non-pharmacological aspects of acute pain management. [2019]In this paper, non-pharmacological aspects of acute pain management were explored. Much of the research to date with regard to pain management, has been done, addressing the needs of chronic rather than acute pain. It is thought that misconceptions are still held by some health care professionals regarding the adequacy of pharmacology to deal totally with the problems of acute pain management, and it is of more importance to concentrate on issues associated with chronic pain. This is borne out by the relative attention paid to acute and chronic pain in the current body of research. Some aspects of non-pharmacological methods of pain management have been well researched over the last 20 to 30 years, whilst others are more recent innovations. Non-pharmacological aspects of acute pain management were examined under two headings: 1. Psychological approaches: including preoperative information giving, cognitive methods, relaxation training, distraction, guided imagery, humour, hypnosis, music and biofeedback. 2. Complementary therapies and other techniques: including both hands on and other physical therapies using equipment: massage, aromatherapy, reflex zone therapy, acupuncture, shiatsu, therapeutic touch and TENS. There is a sound body of knowledge to support the use of many of the established nonpharmacological methods in the management of acute pain. These include: appropriate preoperative information giving, preoperative relaxation, guided imagery and breathing training, cognitive reframing, distraction in both visual and auditory (music) forms, massage, acupuncture, TENS. Other methods which may be of assistance in acute pain management but are inconclusive in their effect from the current body of available research and may require further examination include: hypnosis, humour therapy, biofeedback techniques, aromatherapy, reflex zone therapy, shiatsu, Therapeutic Touch.
No. 355-Physiologic Basis of Pain in Labour and Delivery: An Evidence-Based Approach to its Management. [2022]To review the evidence relating to nonpharmacological approaches in the management of pain during labour and delivery. To formulate recommendations for the usage of nonpharmacological approaches to pain management.
Complementary therapies for cancer pain. [2019]Pharmacologic treatment of pain does not always meet patients' needs and may produce difficult side effects. Complementary therapies, which are safe, noninvasive, and generally considered to be relatively free of toxicity, may be used adjunctively with standard pain management techniques to improve outcome and reduce the need for prescription medication. Approaches such as acupuncture, massage therapy, mind-body interventions, and music therapy effectively reduce pain, enhance quality of life, and provide patients with the opportunity to participate in their own care. Such therapies have an important role in modern pain management.
Pain clinics and pain clinic treatments. [2019]Chronic pain is multi-factorial, and consequently a multidisciplinary approach is essential for its proper management. Pain Clinics may treat acute pain, chronic pain and cancer pain, and need to differentiate between these different conditions. Careful diagnosis and assessment is essential, including history, examination, questionnaires and relevant investigations. A variety of treatments exist to manage chronic pain, some of which have already been discussed in this issue. Treatments may be summarized as drugs, surgical (including nerve blocks), stimulation techniques, psychological techniques and general or physical measures. If a Pain Relief Unit has the ability to provide all of these types of treatment, then it can manage any type of pain, with the ability to relieve pain and improve quality of life greatly in a significant number of sufferers.