Dry needling and upper cervical spinal manipulation in patients with temporomandibular disorder: A multi-center randomized clinical trial

Figures & data

Table 1. Exclusion Criteria

Exclusion Criteria

History of traumatic injury or surgery related to temporomandibular disorder (TMD). Symptoms indicative of disc displacement, arthrosis, or arthritis of the temporomandibular joint (TMJ), consistent with category II and III of the Research Diagnostic Criteria for temporomandibular disorders. Concomitant diagnosis of any primary headache (i.e., tension type headache or migraine) except cervicogenic headaches. Diagnosis of fibromyalgia. Diagnosis of systematic disease such as rheumatoid arthritis, lupus erythematosus, or psoriatic arthritis. Presence of neurologic disorder such as trigeminal neuralgia. Having received physical therapy, chiropractic, acupuncture, or splint treatment for TMD within the last 3 months. History of taking prescription nonsteroidal anti-inflammatory drugs (NSAIDs) within the last 3 months. History of taking non-prescription NSAIDs (i.e. more than intermittently) within the last 3 months. Known sensitivity to acetylsalicylic acid with impaired coagulation or with ulcer, kidney, or liver dysfunction. Presence of a cardiac pacemaker, metal allergy, or severe needle phobia. Serious cardiovascular disease, psychiatric disorder, or cognitive impairment. One or more contraindications to dry needling or manual therapy. Currently pregnant.

Table 2. Baseline characteristics by treatment assignment

Baseline Variable	Dry Needling + Spinal Manipulation (n = 62)	Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)
Gender (male/female)	16/46	14/44
Age (years)	40.2 ± 12.4	43.0 ± 13.1
Weight (kg)	73.2 ± 14.5	72.8 ± 14.6
Height (cm)	169.8 ± 8.1	170.0 ± 8.5
Duration of symptoms (years)	7.3 ± 8.2	6.8 ± 7.6
Number of treatment sessions	6.3 ± 1.9	6.6 ± 1.7
Average jaw pain intensity over the last 7 days (VAS, 0–100)	53.9 ± 13.7	53.5 ± 13.6
Jaw pain intensity over the past 24 hrs (VAS, 0–100)	48.8 ± 15.2	49.6 ± 13.3
Active pain-free mouth opening (mm)	32.0 ± 6.9	32.3 ± 7.6

Data are mean (SD), except for gender. VAS: Visual analog scale, 0–100, lower scores indicate greater function; Active pain-free mouth opening, higher scores indicate less pain and greater function; mm: Millimeters; NSAIDs: Nonsteroidal anti-inflammatory drugs.

Figure 1. Standardized protocol (7 needles) for dry needling for temporomandibular disorder (TMD).

Figure 2. High-velocity low-amplitude thrust manipulation targeting the upper cervical spine.

Figure 3. CONSORT flow diagram of patient recruitment and retention.

Table 3. Within-group and between-group mean scores by randomized treatment assignment

Outcomes	Timeline Scores: Mean ± SD (95% CI) Within-Group Change Scores: Mean (95% CI)		Between-Group Differences: Mean (95% CI)
	Dry Needling + Spinal Manipulation (n = 62)	Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)
Average jaw pain intensity over the last 7 days (VAS 0–100)
Baseline	53.9 ± 13.7 (50.4, 57.4)	53.5 ± 13.6 (49.9, 57.0)
2 weeks	23.9 ± 12.7 (20.7, 27.1)	37.4 ± 17.3 (32.8, 41.9)
Change baseline → 2 weeks	−30.0 (−34.5, −25.5)	−16.1 (−20.4, −11.8)	−13.9 (−20.1, −7.7); SMD = 0.81; p< 0.001
6 weeks	15.5 ± 15.4 (11.6, 19.4)	34.0 ± 15.9 (29.9, 38.2)
Change baseline → 6 weeks	−38.4 (−42.9, −33.8)	−19.4 (−24.0, −14.9)	−19.0 (−25.4, −12.6); SMD = 1.07; p< 0.001
3 months	14.4 ± 16.2 (10.3, 18.5)	35.8 ± 16.5 (31.5, 40.2)
Change baseline → 3 months	−39.5 (−44.9, −34.0)	−17.6 (−22.3, −12.9)	−21.9 (−29.1, −14.7); SMD = 1.10; p< 0.001
Jaw pain intensity over the past 24 hours (VAS 0–100)
Baseline	48.8 ± 15.2 (45.0, 52.7)	49.6 ± 13.3 (46.1, 53.1)
2 weeks	21.2 ± 16.1 (17.1, 25.3)	34.1 ± 16.9 (29.6, 38.5)
Change baseline → 2 weeks	−27.6 (−32.3, −23.0)	−15.6 (−19.7, −11.4)	−12.1 (−18.2, −5.9); SMD = 0.71; p< 0.001
6 weeks	12.7 ± 15.4 (8.7, 16.6)	31.8 ± 17.8 (27.2, 36.5)
Change baseline → 6 weeks	−36.1 (−40.4, −31.9)	−17.8 (−21.9, −13.7)	−18.4 (−24.2, −12.5); SMD = 1.14; p< 0.001
3 months	13.2 ± 16.6 (9.0, 17.4)	33.1 ± 17.5 (28.5, 37.7)
Change baseline → 3 months	−35.6 (−40.7, −30.5)	−16.6 (−20.7, −12.4)	−19.1 (−25.7, −12.5); SMD = 1.05; p< 0.001
Active pain-free mouth opening (mm)
Baseline	32.0 ± 6.9 (30.2, 33.7)	32.3 ± 7.6 (30.3, 34.4)
2 weeks	39.8 ± 8.6 (37.6, 42.0)	34.9 ± 7.3 (33.0, 36.8)
Change baseline → 2 weeks	7.8 (6.1, 9.5)	2.6 (1.6, 3.5)	5.3 (3.3, 7.2); SMD = 0.96; p< 0.001
6 weeks	42.7 ± 8.5 (40.5, 44.8)	35.9 ± 6.6 (34.1, 37.6)
Change baseline → 6 weeks	10.7 (8.9, 12.6)	3.5 (2.4, 4.7)	7.2 (5.1, 9.4); SMD = 1.21; p< 0.001
3 months	44.1 ± 7.9 (42.1, 46.1)	35.4 ± 7.4 (33.4, 37.3)
Change baseline → 3 months	12.1 (10.4, 13.9)	3.0 (2.0, 4.1)	9.1 (7.1, 11.1); SMD = 1.61; p< 0.001

VAS: Visual analog scale, 0–100, lower scores indicate greater function; Active pain-free mouth opening, higher scores indicate less pain and greater function; mm: Millimeters; SMD: Standardized mean difference; SD: Standard deviation; CI: Confidence interval; NSAIDs: Nonsteroidal anti-inflammatory drugs

Figure 4. Evolution of average jaw pain intensity over the last 7 days (VAS) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.

Figure 5. Evolution of active pain-free mouth opening (mm) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.

Figure 6. Evolution of jaw pain intensity over the past 24 hrs (VAS) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.

Table 4. Self-perceived improvement measured with the Global Rating of Change (GROC) in both groups [n (%)]

Global Rating of Change (GROC, −7 to +7)	Dry Needling + Spinal Manipulation (n = 62)	Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)
3 months after the first treatment session
Small changes (+2/+3)	2 (3.2%)/6 (9.7%)	13 (22.4%)/8 (13.8%)
Moderate changes (+4/+5)	3 (4.8%)/12 (19.4%)	6 (10.3%)/11 (19.0%)
Large changes (+6/+7)	16 (25.8%)/16 (25.8%)	2 (3.4%)/3 (5.2%)

NSAIDs: Nonsteroidal anti-inflammatory drugs.