Exercise intervention for the treatment of trismus in head and neck cancer – a prospective two-year follow-up study

Figures & data

Figure 1. Engström jaw device (above) and TheraBite® jaw device, Atos Medical, Sweden (below).

Figure 2. Study flow chart.

Table 1. Patient characteristics in the intervention group and the control group at start of study.

	Intervention group n = 50 Mean (range/%)	Control group n = 50 Mean (range/%)	p-Value
Age mean (range)	57.9 (55–61)	58.0 (55–61)	ns
Gender
Male	31 (62)	31 (62)
Female	19 (38)	19 (38)	ns
Treatment regimen
Radiotherapy only	8 (16)	8 (16)
Radiochemotherapy	39 (78)	38 (76)
Radiotherapy + surgery	3 (6)	4 (8)	ns
Tumor location
Orofarynx	38 (76)	38 (76)
Tumor colli	6 (12)	6 (12)
Oral cavity	1 (2)	1 (2)
Nasofarynx	5 (10)	5 (10)	ns
Stadium^a
1	1 (2)	0 (0)
2	8 (18)	4 (9)
3	8 (18)	12 (27)
4	27 (61)	28 (64)	ns
ACE-27
No comorbidity	29 (58)	20 (40)
Mild comorbidity	13 (26)	18 (36)
Moderate comorbidity	7 (14)	10 (20)
Severe comorbidity	1 (2)	2 (4)	ns
Educational level (school years)	10.4 (7–14)	10.7 (8–13)	ns

ACE-27, Adult Comorbidity Evaluation; ns, not significant.

^amissing data n = 6 in each group since tumor colli/unknown primary is not classified.

Table 2. MIO, mean value, 95% confidence interval (CI) for HNC patients before and after intervention and at 2-year follow-up.

MIO (mm)	Before intervention Mean (CI)	After intervention Mean (CI)	2-year follow-up |Mean (CI)
Intervention group	n = 50	n = 50	n = 44
	32.2 (31–33)	38.6 (37–40)	40.5 (39–42)
Control group	n = 50	n = 50	n = 43
	33.2 (32–34)	33.9 (33–35)	34.3 (32–36)
p-Value	ns	***	***

*p < 0.05; ***p < 0.001. MIO, maximal interincisal opening; ns, not significant.

Table 3. GTQ-score for HNC patients before and after trismus intervention and at 2-year follow-up.

	Before intervention			After intervention			2-year follow-up
GTQ	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 44 Mean (CI)	Control group, n = 43 Mean (CI)	p-Value
Jaw-related problems	41.4 (36–47)	41.5 (35–48)	ns	22.9 (17–29)	43.1 (37–49)	***	13.2 (9–17)	42.5 (36–49)	***
Eating limitations	46.5 (37–56)	40.0 (33–47)	ns	28.1 (21–35)	39.5 (33–46)	*	8.7 (5–12)	39.3 (31–47)	***
Muscular tension	26.3 (22–31)	23.8 (18–29)	ns	13.2 (10–17)	27.5 (22–33)	***	13.5 (9–18)	33.5 (26–41)	***
Facial pain right now	24.3 (18–31)	20.7 (14–27)	ns	9.0 (4–14)	20.7 (15–26)	***	3.6 (1–6)	15.1 (9–21)	**
Facial pain when worst last month	43.0 (36–51)	40.3 (33–48)	ns	22.7 (16–29)	30.7 (24–38)	ns	8.9 (5–13)	26.2 (18–34)	***
Facial pain average value	38.3 (32–45)	35.3 (28–43)	ns	21.0 (15–27)	30.0 (23–37)	ns	6.7 (3–10)	22.2 (16–29)	***
Facial pain interfering with social. leisure and family activities	24.0 (16–32)	23.5 (16–31)	ns	15.0 (7–23)	20.0 (13–27)	ns	1.1 (0–3)	14.9 (9–21)	***
Facial pain affecting ability to work	25.0 (17–33)	23.5 (15–32)	ns	13.5 (6–21)	21.0 (14–28)	*	1.1 (0–3)	17.9 (11–25)	***
Limitation in opening mouth (LOM)	49.0 (43–55)	45.0 (36–54)	ns	33.0 (26–40)	40.0 (33–47)	ns	18.6 (13–24)	41.1 (33–50)	***
LOM interfering with social, leisure and family activities	24.0 (18–30)	24.5 (17–32)	ns	16.5 (8–25)	26.5 (20–33)	**	1.6 (0–3)	18.5 (12–25)	***
LOM affecting ability to work	24.5 (16–33)	25.0 (17–33)	ns	14.0 (6–22)	22.0 (15–30)	*	0.5 (−1–2)	14.9 (9–21)	***

Domains and single items range 0–100, where 100 indicate maximal amount of symptoms and 0 is equal to no symptoms. p-Values for analysis of statistical significant difference in mean scores between the intervention group and the control group, before and after intervention and at 2-year follow-up.

*p < 0.05; **p < 0.01; ***p < 0.001. CI, 95% confidence interval; GTQ, Gothenburg Trismus Questionnaire; ns, not significant.

Table 4. EORTC QLQ C30-score for HNC patients before and after intervention and at 2-year follow-up.

	Before intervention			After intervention			2-year follow-up
	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 44 Mean (CI)	Control group, n = 43 Mean (CI)	p-Value
Functional domains
Physical functioning	73.9 (69–79)	72.7 (66–79)	ns	83.7 (79–88)	79.6 (74–85)	ns	90.9 (88–94)	78.7 (72–86)	*
Role functioning	46.0 (36–56)	52.3 (43–61)	ns	61.7 (53–71)	63.7 (55–72)	ns	87.6 (82–93)	64.3 (53–75)	**
Emotional functioning	70.3 (64–77)	72.0 (65–79)	ns	82.9 (77–88)	75.5 (68–83)	ns	80.7 (75–87)	74.1 (65–83)	ns
Cognitive functioning	76.0 (71–82)	76.0 (68–84)	ns	82.7 (76–89)	75.3 (68–83)	ns	85.1 (80–90)	75.4 (67–84)	ns
Social functioning	56.7 (48–65)	61.0 (52–70)	ns	70.7 (63–79)	67.3 (59–76)	ns	87.9 (82–94)	65.5 (56–76)	***
Global quality of life	54.2 (49–60)	58.0 (53–63)	ns	66.3 (61–72)	57.2 (51–63)	*	76.1 (71–81)	58.5 (51–66)	***
Symptoms domains
Fatigue	49.6 (43–57)	45.0 (37–53)	ns	34.0 (26–42)	36.3 (29–44)	ns	18.0 (13–23)	35.4 (26–45)	**
Nausea/vomiting	15.7 (10–21)	13.0 (7–19)	ns	9.3 (3–16)	8.33 (3–13)	ns	3.9 (2–6)	10.7 (5–16)	ns
Pain	36.3 (28–45)	36.0 (29–44)	ns	21.7 (15–29)	27.0 (20–34)	ns	9.2 (5–13)	23.0 (14–32)	*
Single items
Dyspnea	36.7 (29–45)	37.3 (29–46)	ns	24.0 (18–30)	25.3 (18–33)	ns	14.2 (9–20)	28.6 (18–39)	*
Insomnia	24.0 (17–31)	32.7 (24–42)	ns	23.3 (17–30)	21.1 (14–29)	ns	21.3 (14–29)	27.8 (18–37)	ns
Appetite loss	49.3 (40–59)	46.3 (37–56)	ns	36.1 (26–46)	35.3 (26–45)	ns	15.6 (9–22)	27.8 (17–39)	ns
Constipation	26.0 (17–35)	24.0 (16–32)	ns	14.0 (6–22)	16.7 (9–25)	ns	12.1 (4–20)	11.9 (5–19)	ns
Diarrhea	10.7 (5–16)	12.0 (6–18)	ns	17.0 (9–25)	10.0 (5–16)	ns	6.4 (2–11)	12.7 (6–20)	ns
Financial problems	19.3 (12–26)	30.0 (20–40)	ns	13.3 (7–20)	29.3 (19–40)	*	5.1 (1–9)	27.8 (16–40)	**

Score range 0–100 points. High scores for a functional domain and the global quality of life domain represent high level of functioning or high level of global quality of life. High scores for a single item represent high level of symptoms. p-Values for analysis of statistical significant difference in mean scores between the intervention group and the control group, before and after intervention and at 2-year follow-up.

*p < 0.05; **p < 0.01; ***p < 0.001. CI, 95% confidence interval; ns, not significant.

Table 5. EORTC QLQ H&N35-score for HNC patients before and after intervention and at 2-year follow-up.

EORTC HN35	Before intervention			After intervention			2-year follow-up
Symptom domains	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 50 Mean (CI)	Control group, n = 50 Mean (CI)	p-Value	Intervention group, n = 44 Mean (CI)	Control group, n = 43 Mean (CI)	p-Value
Pain	41.3 (34–49)	39.4 (32–47)	ns	30.0 (23–37)	33.8 (27–41)	ns	17.2 (12–22)	29.1 (21–37)	ns
Swallowing	43.6 (36–51)	38.8 (31–47)	ns	32.3 (25–39)	35.4 (27–44)	ns	22.9 (16–30)	31.2 (22–40)	ns
Senses	37.0 (30–44)	39.7 (32–48)	ns	26.7 (19–34)	32.0 (25–39)	ns	19.9 (13–27)	29.3 (21–38)	ns
Speech	30.9 (24–38)	28.0 (21–35)	ns	19.1 (13–25)	25.4 (19–32)	ns	9.2 (6–13)	21.4 (13–30)	*
Social eating	45.4 (37–54)	42.3 (35–50)	ns	31.8 (25–38)	42.3 (34–50)	ns	22.2 (15–29)	34.9 (25–45)	ns
Social contact	19.6 (12–27)	16.4 (10–22)	ns	10.0 (5–15)	16.0 (10–23)	ns	4.3 (2–7)	12.1 (6–18)	*
Sexuality	56.6 (47–66)	59.7 (49–71)	ns	45.1 (34–56)	47.3 (37–58)	ns	28.9 (20–38)	38.0 (27–49)	ns
Single items
Teeth	24.0 (16–32)	24.7 (16–33)	ns	20.7 (13–29)	29.9 (21–39)	ns	10.6 (5–16)	29.3 (18–41)	**
Opening mouth	44.0 (37–51)	45.3 (37–54)	ns	30.7 (21–40)	45.3 (37–54)	**	18.4 (13–24)	35.0 (25–45)	*
Dry mouth	79.3 (72–87)	82.7 (75–91)	ns	71.3 (63–80)	78.2 (70–87)	ns	62.4 (53–72)	73.2 (64–83)	ns
Sticky saliva	66.7 (56–77)	69.4 (60–79)	ns	54.7 (45–65)	62.6 (53–73)	ns	49.6 (40–60)	54.2 (43–65)	ns
Cough	32.0 (22–42)	30.0 (21–39)	ns	28.0 (19–37)	32.0 (22–42)	ns	22.0 (14–30)	29.2 (20–39)	ns
Felt ill	31.3 (22–41)	29.3 (21–37)	ns	20.7 (12–29)	22.9 (14–31)	ns	10.1 (6–15)	25.2 (15–35)	*

Score range 0–100 points. High scores for a single item represent high level of symptoms. p-Values for analysis of statistical significant difference in mean scores between the intervention group and the control group, before and after intervention and at 2-year follow-up.

*p < 0.05; **p < 0.01; ***p < 0.00. CI, 95% confidence interval; ns, not significant.