Manual therapy, physical therapy, or continued care by a general practitioner for patients with neck pain. A randomized, controlled trial.
Context Neck pain is common among primary care patients. Evidence on the effectiveness of therapies for neck pain is limited. A previous randomized, controlled trial suggested benefits from manual therapy and physical therapy. Contribution This randomized, controlled trial of manual therapy, physical therapy, and continued care by a doctor confirms the superiority of manual therapy and physical therapy over continued care. At 7 weeks, 68.3% of patients in the manual therapy group reported resolved or much improved pain, compared with 50.8% of patients in the physical therapy group and 35.9% of patients in the continued care group. Clinical Implications Primary care physicians should consider manual therapy when treating patients with neck pain. The Editors Neck pain is a common problem in the general population, with point prevalences between 10% and 15% (1-3). It is most common at approximately 50 years of age and is more common in women than in men (1, 2, 4-6). Neck pain can be severely disabling and costly, and little is known about its clinical course (7-9). Limited range of motion and a subjective feeling of stiffness may accompany neck pain, which is often precipitated or aggravated by neck movements or sustained neck postures. Headache, brachialgia, dizziness, and other signs and symptoms may also be present in combination with neck pain (10, 11). Although history taking and diagnostic examination can suggest a potential cause, in most cases the pathologic basis for neck pain is unclear and the pain is labeled nonspecific. Conservative treatment methods that are frequently used in general practice include analgesics, rest, or referral to a physical therapist or manual therapist (12, 13). Physical therapy may include passive treatment, such as massage, interferential current, or heat applications, and active treatment, such as exercise therapies. Physical therapists can specialize in passive manual (or hands-on) techniques, including mobilization or manipulation (high-velocity thrust techniques), also referred to as manual therapy (14-19). According to the International Federation of Orthopedic Manipulative Therapies, Orthopedic manipulative (manual) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities (unpublished data). Today, many different manual therapy approaches are applied by various health professionals, including medical doctors, physical therapists, massage therapists, manual therapists, chiropractors, and osteopathic doctors. Reviews of trials involving manual therapy or physical therapy show that most interventions in these categories are characterized by a combination of passive and active components (20-23). Although a combination of manual therapy or physical therapy that includes exercises appears to be effective for neck pain, these therapies have not been studied in sufficient detail to draw firm conclusions, and the methodologic quality of most trials on neck pain is rather low (20-23). Koes and colleagues (24, 25) performed a randomized trial on back and neck pain and found promising results for manual therapy and physical therapy in subgroup analyses of patients with neck pain. In our randomized, controlled trial, we compared the effectiveness of manual therapy, physical therapy, and continued care by a general practitioner in patients with nonspecific neck pain. Methods Patients Patients with nonspecific neck pain whose clinical presentation did not warrant referral for further diagnostic screening were referred to one of four research centers by 42 general practitioners for study selection. We excluded patients whose history, signs, and symptoms suggested a potential nonbenign cause (including previous surgery of the neck) or evidence of a specific pathologic condition, such as malignancy, neurologic disease, fracture, herniated disc, or systemic rheumatic disease. Two research assistants who were experienced physical therapists and were blinded to treatment allocation performed physical examinations at baseline and follow-up. They used standardized inclusion and exclusion criteria and performed a short neurologic examination (Appendix Table 1) and range-of-motion assessment. The eligibility criteria were age between 18 and 70 years, pain or stiffness in the neck for at least 2 weeks, neck symptoms reproducible during physical examination, willingness to adhere to treatment and measurement regimens, no physical therapy or manual therapy for neck pain during the previous 6 months, no involvement in litigation, and written informed consent. Patients with concurrent headaches, nonradicular pain in the upper extremities, and low back pain were not excluded, but neck pain had to be the main symptom for all patients. Random Assignment and Data Collection All patient data were collected before randomization. Patients were assigned to a treatment group on the basis of block randomization after prestratification for symptom severity (severity scores <7 points or 7 points on a scale of 0 to 10); age (<40 years or 40 years); and, mainly for practical reasons, research center (four local centers). Randomized permuted blocks of six patients were generated for each stratum by using a computer-generated random-sequence table. A researcher who was not involved in the project prepared opaque, sequentially numbered sealed envelopes that contained folded cards indicating one of the three interventions. Interventions The intervention period lasted 6 weeks. Patients were allowed to perform exercises at home and to continue medication prescribed at baseline or use over-the-counter analgesics. Other co-interventions were discouraged but were registered if they occurred. Within the boundaries of the protocol, treatment could be reassessed and adapted to the patient's condition. The specific treatment characteristics were registered at each visit. A maximum number of visits was set for each intervention group; however, the patients did not have to complete this maximum number if symptoms had resolved. Manual Therapy Our approach to manual therapy was eclectic and incorporated several techniques used in western Europe, North America, and Australia, including those described by Cyriax, Kaltenborn, Maitland, and Mennel (15, 16, 19). In our trial, manual therapy (defined as the use of passive movements to help restore normal spinal function) included hands-on muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature) (26). Joint mobilization is a form of manual therapy that involves low-velocity passive movements within or at the limit of joint range of motion (27). Manual therapists must undergo extensive training to be able to skillfully perform mobilization techniques (15, 19). Spinal manipulations (low-amplitude, high-velocity thrust techniques) were not included in this protocol. Forty-five minute treatment sessions were scheduled once per week, for a maximum of six treatments. Six experienced manual therapists acknowledged by the Netherlands Manual Therapy Association performed the treatment. Physical Therapy The physical therapists used a combination of several treatment options, but active exercise therapies were the cornerstone of their strategy. Active exercise therapy involves participation by the patient and includes active exercises (to improve strength or range of motion), postural exercises, stretching, relaxation exercises, and functional exercises. Manual traction or stretching, massage, or physical therapy methods, such as interferential current or heat applications, could precede the exercise therapy. Specific manual mobilization techniques were not included in this protocol. Thirty-minute treatment sessions were scheduled twice per week for a maximum of 12 treatments. The treatment was performed by five experienced physical therapists. We prevented cross-contamination with manual therapy by choosing physical therapists who were not manual therapy specialists. Continued Care by a General Practitioner Each patient in this group received standardized care from his or her general practitioner, including advice on prognosis, advice on psychosocial issues, advice on self-care (heat application, home exercises), advice on ergonomics (for example, size of pillow, work position), and encouragement to await further recovery. The treatment protocol was similar to the practice guidelines for low back pain issued by the Dutch College of General Practitioners (28). Patients received an educational booklet containing ergonomic advice and exercises (29). Medication, including paracetamol or nonsteroidal anti-inflammatory drugs, was prescribed on a time-contingent basis if necessary. Ten-minute follow-up visits, scheduled every 2 weeks, were optional, and referral during the intervention period was discouraged. Outcome Measures Data were collected at the research center after 3 and 7 weeks. At 7 weeks, treatment results were expected to be maximal. The patients were repeatedly asked not to reveal any information about their treatment allocation to the research assistants. The success of blinding was evaluated at 7 weeks. Primary outcome measures focused on perceived recovery, pain, and functional disability. Patients rated perceived recovery on a 6-point ordinal transition scale, ranging from much worse to completely recovered. Success was defined a priori as completely recovered or much improved (30). In addition, on the basis of the systematic assessment of spinal mobility, palpation, and pain reported by the